reference id: 4151496 · 2017. 9. 13. · 20 caplets* capsule-shaped tablets ® xx x xxxxx naproxen...

24
Active ingredients (in each caplet) Purposes Diphenhydramine hydrochloride 25 mg ..............................................................Nighttime sleep-aid Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* ................................................ Pain reliever nonsteroidal anti-inflammatory drug Uses for reief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night’s sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on sk n if you have sleeplessness without pain Ask doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, iver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have a breathing problem such as emphysema or chronic bronch tis you have glaucoma you have rouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid under a doctor’s care for any serious condition taking any other antihistamines taking any other drug When using his product drowsiness w ll occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk f stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the pill is stuck in your throat If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: ake 2 caplets at bedtime do not take more than 2 caplets in 24 hours if taken with food, his product may take longer to work Other information read all warnings and directions before use each caplet contains: sodium 20 mg store at 20-25ºC (68-77ºF) avoid high humidity and excessive heat above 40ºC (104ºF) Inactive ingredients carnauba wax, FD&C blue #2 aluminum lake, hypromelose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pur fied water, talc, titanium dioxide Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST) Dist. by: Bayer HealthCare LLC, Whippany, NJ 07981 MADE IN GERMANY XXXXX naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCl, 25 mg Pain reliever/nighttime sleep-aid 2 caplets * CAPSULE-SHAPED TABLETS * ® While folded on line, tear open at dot or use scissors. Do not use if pouch is torn or open Reference ID: 4151496

Upload: others

Post on 01-Mar-2021

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

Active ingredients (in each caplet) PurposesDiphenhydramine hydrochloride 25 mg ..............................................................Nighttime sleep-aidNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)* ................................................ Pain relievernonsteroidal anti-inflammatory drug

Uses • for re ief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • unless you have time for a full night’s sleep • in children under 12 years of age • right before or after heart surgery • with any other

product containing diphenhydramine, even one used on sk n • if you have sleeplessness without pain Ask doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, iver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic • you have a breathing problem such as emphysema or chronic bronch tis • you have glaucoma • you have rouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if

you are • taking sedatives or tranquilizers, or any other sleep-aid • under a doctor’s care for any serious condition • taking any other antihistamines • taking any other drug When using his product • drowsiness w ll occur • avoid alcoholic drinks • do not drive a motor vehicle

or operate machinery • take with food or milk f stomach upset occurs Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • redness or swelling is present in the painful area • any new symptoms appear • you have difficulty swallowing • it feels like the pill is stuck in your throat If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions • do not take more than directed • drink a full glass of water with each dose • adults and children 12 years and over: ake 2 caplets at bedtime • do not take more than 2 caplets in 24 hours • if taken with food, his product may take longer to work Other information • read all warnings and directions

before use • each caplet contains: sodium 20 mg • store at 20-25ºC (68-77ºF) • avoid high humidity and excessive heat above 40ºC (104ºF) Inactive ingredients carnauba wax, FD&C blue #2 aluminum lake, hyprome lose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pur fied water, talc, titanium dioxide Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST)Dist. by: Bayer HealthCare LLC, Whippany, NJ 07981 MADE IN GERMANY XXXXX

naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCl, 25 mgPain reliever/nighttime sleep-aid

2 caplets *CAPSULE-SHAPED TABLETS*

®

While folded on line, tear open at dot or use scissors.Do not use if pouch is torn or open

Reference ID: 4151496

Page 2: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

®

naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCI, 25 mgPa n reliever/nigh time sleep aid

Sleep Aid PLUS 12 Hour Pain Relieving Strength of Aleve

D s Ba a Ca C W a 0798

Ba Ba C ss a A a s a ma s f Ba

MADE N GERMAN

®

Sleep Aid PLUS 12 Hour Pain Relieving Strength of Aleve

naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCI, 25 mgPa n reliever/nigh time sleep aid

EXP

LOT

®

naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCI, 25 mgPain reliever/nighttime sleep-aid

Sleep Aid PLUS 12 Hour Pain Relieving Strength of Aleve

®

naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCI, 25 mgPain reliever/nighttime sleep-aid

Drug FactsAct ve ingred en s (in each cap et) PurposesDi henhyd amine h droc lo de 25 mg Nigh time leep a dNapr xen sodium 220 mg (nap oxen 200 mg) NSAID)* Pain eliever*no ste o dal an i inflammato y drug

Uses • f r re ief of oc asional lee le sness when as ociated with min r aches and pains• helps you fa l sl ep nd tay asleep

WarningsAllergy alert N pro en odi m m y ause a s vere a lergic reac ion esp ci lly in people alle gic o a pi in S mp oms may include• hi es • facial w l ing • as hma (wheezing) • shock• skin eddening • ash • b iste sIf an a lergic re ction occu s s op use and seek me ic l help ight awayStomach bleeding wa ning This p oduct ontains an NSA D which may cau e sev re st mach bleeding The chan e is higher if ou• are age 60 or o der• have had s oma h ulce s or bl edi g p oblems• take a blood thinning (an i oagulan ) or st ro d drug• take o her d ugs con ai ing p esc ip ion or onpre crip ion NSAIDs (a pi in

ibu rofen nap oxen or oth rs)• have 3 or mo e al oho ic drinks e ery day wh le using this prod ct• take mo e or for a l nger time han direc edHeart a ta k and s roke w rning NSA Ds ex ept aspirin inc ease the isk of hea t at ack heart fa l re and s roke The e c n be fatal The isk is higher if ou use m re than dire ted or for longer han i ec edDo not use • if ou have ever had an aller ic r action to any o her pain eliev r fev r redu er• unless you have time for a fu l night’s sleep• in ch dren under 12 yea s of age• right before or after heart s rge y• wi h a y o her p oduct c ntaining iphe hydr mine e en one used on skin• if ou have sle ple sness wi hout pain

D ug Facts (continued)Ask a doc or befo e u e f• s oma h bleeding warning app ies o ou• you ha e p oblems or se i us s de ffec s f om aking pain re ieve s r f ver educe s• you have a hi to y f st mach p oblems such as hear bu n• you have high lood p essu e hea t disease liver ci rhosis idn y dise se

asthma r had a s roke• you are aking a diure ic• you have a brea hing problem s ch s emph sema or hronic bro chi is• you have glaucoma• you have rouble urina ing due o an enlarg d p os ate gland

Ask a doc or or pharmacist befo e u e f you are• ta ing sed tives or ranq i i ers or any other sleep a d• under a doc or’s ca e for any se ious condition• ta ing any o her an i is amin s• ta ing any o her d ug

Wh n using his p oduct• drow ine s w ll occur• avo d al oho ic drinks• do not drive a mo or ve icle or ope ate machinery• take with food or m k f s omach upset o curs

Stop use and sk a doc or if• you expe i nce any of the following sig s of stomach bleeding

• feel faint • vomit blood • have bl ody r bl ck stools• have stomach pain tha does not get be er

• you have symp oms of heart p oblems or t oke• hest pain • t ouble brea hing• weakness in one pa t or s de of body• lu red sp ech • leg swe ing

• pain g ts worse or las s mo e han 10 days• sleeplessne s p rsis s ontinuou ly for m re than 2 weeks Insomnia may be a

symptom of a serious unde l ing medical llness • red ess or swe ling is p esent in the painful ar a• any new ym toms appear• you have d f i ul y swa lowing• i feels l ke he p l is tuck in your hroat

Drug Facts (con inued)If p egnant or brea t feeding ask a health pr fe sio al before use It is e pecially impo ta t not o use napro en sodium du ing he last 3 mon hs of pregn ncy unless definitely direc ed to do so by a doc or becau e it may cause pro lems in he nborn ch d or omp ica ions du ing d live yK ep out of each of chi dr n In ase of ove dose et m di al help or ont ct a Poi on Con rol C nter i ht away

Di ec ions • do not ake more han direc ed• drink a fu l glass of water w h ea h do e• dul s and ch ld en 12 ears and over ake 2 c ple s at bed ime• do no take more han 2 ca le s in 24 hou s• f aken wi h food this product may take longer o wo k

Other n o mation • ead all wa nings and di ections befo e use • ach aplet con ains odium 20 mg• to e t 20 5°C 68 77°F) • vo d high humidi y nd e cessive heat above 40°C (104 F)

Inac ive ngredien s carn uba wax FD&C blue 2 alumin m l ke hy romellose ma nesium st ara e mi roc ys al ine cellulose ol eth lene glycol po ido e pur ied wa er alc i anium diox de

Ques ions or comments? 1 800-3 5-0689 (Mon F i 9AM 5PM EST)

®

Sleep Aid PLUS 12 Hour Pain Relieving Strength of Aleve

naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCI, 25 mgPain reliever/nighttime sleep-aid

Do not use if pouch is torn or open

36 TWO CAPLET* POUCHESCAPSULE-SHAPED TABLETS

Reference ID: 4151496

Page 3: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

20

ca

plets

*CAPSULE-SHAPED TABLETS

®

XX

XX

XX

XX naproxen sodium

, 220 mg (NSAID)/

diphenhydramine HCI, 25 m

gPain reliever/nighttim

e sleep-aid

Sleep

Aid

PLU

S12 H

ou

r Pa

in R

elievin

gS

tren

gth

of A

leve

Reference ID: 4151496

Page 4: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

LIFT

HERE

help right away. Stomach bleeding warning: This

product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if

you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning

(anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoho ic

drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except asprin, increase the risk of heart attack, heart

failure, and stroke. These can be fatal. The risk

is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor or pharmacist before use if you are taking any other drug If pregnant or breast-feeding, ask a health professional before use. Directions Do not take more than directed. Adu ts and children 12 years and over: take 2 caplets with a full glass of water at bedtime. Do not take more than 2 caplets in 24 hours. Questions or comments? 1-800-395-0689 (Mon-Fri 9AM – 5PM EST)Dist. by: Bayer HealthCare LLC, Whippany, NJ 07981

Do not use if foil sealimprinted with "SAFETY SQUEASE"

on bottle opening is missing or broken. See Carton For Full Information. Active ingredients (in

each caplet) Diphenhydramine hydrochloride 25 mg, Naproxen sodium 220 mg (naproxen 200 mg) Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives

• facial swelling • asthma (wheezing) • shock • skin reddening • rash

• blisters. If an allergic reaction occurs, stop use and seek medical XXXXXXXX

Reference ID: 4151496

Page 5: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

XXXXXXXX

0000

Do not use if carton is open or if foil seal imprinted with "SAFETY SQUEASE" on bottle opening is missing or broken

Bayer, the Bayer Cross and Aleve areregistered trademarks of Bayer.

Dist by:Bayer Hea thCare LLCWh ppany NJ 07981

MADE IN GERMANY

Sa ety Squease is a registeredtrademark of The Procter & Gamb eCompany Used w th permission

LOT/EXP

Drug FactsActive ingredients Purposes(in each caplet)Diphenhydramine hydrochloride 25 mg Nighttime sleep aidNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)* Pain reliever*nonsteroidal anti inflammatory drug

Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep

WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people a le gic to aspirin Symptoms may include • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blistersIf an allergic eaction occurs, stop use and seek medical help right awayStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding The chance is higher f you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (an icoagulant) or steroid drug • take other drugs containing prescription or nonprescrip ion NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoho ic drinks every day while using his product • take more or for a longer time than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart a tack, heart failure, and stroke These can be fatal The risk is higher f you use more than directed or for longer han directed

Drug Facts (continued)Do not use • if you have ever had an a lergic reaction to any other pain reliever/fever reducer • unless you have time for a fu l night’s sleep • in children under 12 years of age • right before or after heart surgery • with any other product containing diphenhydramine, even one used on skin • f you have sleeplessness w thout pain

Ask a doctor before use if • stomach bleeding warning app ies to you • you have problems or serious side effects from taking pain elievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver ci rhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic • you have a brea hing problem such as emphysema or chronic bronchi is • you have glaucoma • you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are • taking sedatives or tranqu lizers, or any other sleep aid • under a doctor’s care for any serious condition • taking any other antihistamines • taking any o her drug

When using this product • drowsiness w ll occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery • take with food or milk f stomach upset occurs

Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get be ter • you have symptoms of heart problems or stroke • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • sleeplessness persists continuously for more than 2 weeks Insomnia may be a symptom of a serious underlying medical i lness • redness or swe ling is present in the painful area • any new symptoms appear • you have di ficulty swallowing • it feels like the pi l is stuck in your hroat

Drug Facts (continued)If pregnant or breast feeding, ask a hea th professional befo e use t is especia ly important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because t may cause problems in the unborn child or complications during deliveryKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Directions • do not take more than directed • drink a fu l glass of water with each dose • adults and ch ldren 12 years and over take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours • f taken wi h food, this product may take longer to work

Other information • read all warnings and directions before use. Keep outer carton. • each caplet contains: sodium 20 mg • store at 20 25°C (68 77°F) • avoid high humid ty and excessive heat above 40°C (104°F)

Inactive ingredients carnauba wax, FD&C blue #2 aluminum lake, hyprome lose, magnesium stearate, microcrystal ine cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide

Questions or comments? 1 800 395 0689 (Mon Fri 9AM 5PM EST)

20 c

ap

lets

*CAPSULE-SHAPED TABLETS

Sle

ep

Aid

PLU

S12

Ho

ur

Pa

in R

elie

vin

gS

tr

en

gt

h o

f A

lev

e

®

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCI, 25 mg

Pain reliever/nighttime sleep-aid

Reference ID: 4151496

Page 6: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

40

ca

plets

*CAPSULE-SHAPED TABLETS

®

XX

XX

XX

XX naproxen sodium

, 220 mg (NSAID)/

diphenhydramine HCI, 25 m

gPain reliever/nighttim

e sleep-aid

Sleep

Aid

PLU

S12 H

ou

r Pa

in R

elievin

gS

tren

gth

of A

leve

Reference ID: 4151496

Page 7: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

LIFT

HERE

help right away. Stomach bleeding warning: This

product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if

you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning

(anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoho ic

drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except asprin, increase the risk of heart attack, heart

failure, and stroke. These can be fatal. The risk

is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor or pharmacist before use if you are taking any other drug If pregnant or breast-feeding, ask a health professional before use. Directions Do not take more than directed. Adu ts and children 12 years and over: take 2 caplets with a full glass of water at bedtime. Do not take more than 2 caplets in 24 hours. Questions or comments? 1-800-395-0689 (Mon-Fri 9AM – 5PM EST)Dist. by: Bayer HealthCare LLC, Whippany, NJ 07981

Do not use if foil sealimprinted with "SAFETY SQUEASE"

on bottle opening is missing or broken. See Carton For Full Information. Active ingredients (in

each caplet) Diphenhydramine hydrochloride 25 mg, Naproxen sodium 220 mg (naproxen 200 mg) Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives

• facial swelling • asthma (wheezing) • shock • skin reddening • rash

• blisters. If an allergic reaction occurs, stop use and seek medical XXXXXXXX

Reference ID: 4151496

Page 8: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

0000XXXXXXXX Do not use if carton is open or if fo l seal imprinted with

"SAFETY SQUEASE" on bottle opening is missing or broken.

Dist by:Bayer HealthCare LLCWhippany NJ 07981MADE IN GERMANY

Sa e y Squease is a regis eredtrademark of The Procter & GambleCompany Used wi h permission

Bayer, the Bayer Cross and Aleve areregistered trademarks of Bayer.

LOT/EXP

Drug FactsActive ingredients Purposes(in each caplet)Diphenhydramine hydrochlo ide 25 mg .... ...Nighttime sleep-aidNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)*... ...Pain reliever*nonsteroidal anti-in lammatory drug

Uses• for re ief of occasional sleeplessness when

associated with minor aches and pains

• helps you fall asleep and stay asleep

WarningsAllergy alert: Naproxen sodium may cause a severe allergic eaction especia ly in people a lergic to aspirin. Symptoms may include

• hives • facial swel ing

• asthma (wheezing) • shock

• skin reddening • rash • blistersIf an allergic reaction occurs stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSA D which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older

• have had stomach ulcers or bleeding p oblems

• take a blood thinning (anticoagulant) or steroid drug

• take other drugs containing prescrip ion or nonprescription NSAIDs (aspirin ibuprofen naproxen or others)

• have 3 or more alcoholic drinks every day while using this product

• take more or for a longer time than directedHeart attack and stroke warning: NSAIDs except aspirin increase the risk of heart a tack heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Drug Facts (continued)Do not use• if you have ever had an a lergic reaction to any other pain

re iever fever reducer•• in children under 12 years of age• right before or a ter heart surgery• with any other product containing diphenhydramine even

one used on skin• if you have sleeplessness without painAsk a doctor before use if• stomach bleeding warning app ies to you• you have problems or serious side effects from taking pain

re ievers or fever educers• you have a history of stomach problems such as heartburn• you have high blood p essure heart disease liver cirrhosis

kidney disease asthma or had a stroke• you are taking a diuretic• you have a breathing problem such as emphysema or

chronic bronchitis• you have glaucoma• you have trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are• taking sedatives or tranquilizers or any other sleep-aid•• taking any other antihistamines• taking any other drugWhen using this product• drowsiness w ll occur• avoid alcoholic drinks• do not drive a motor vehicle or operate machinery• take with food or m lk if stomach upset occursStop use and ask a doctor if• you experience any of the following signs of stomach bleeding• feel faint • vom t blood • have bloody or black stools• have stomach pain that does not get better

• you have symptoms of heart problems or stroke• chest pain • trouble breathing• weakness in one part or side of body• slurred speech • leg swelling

• pain gets worse or lasts more than 10 days• sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of a serious underlying medical llness.

• redness or swelling is present in the painful area

Drug Facts (continued)• any new symptoms appear

• you have di ficu ty swa lowing

• it feels like the pill is stuck in your throatIf pregnant or breast-feeding, ask a hea th professional before use. t is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely di ected to do so by a doctor because t may cause problems in the unborn child or complications during de ivery.Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

Directions• do not take more than directed

• drink a full glass of water with each dose

• adults and ch ldren 12 years and over take 2 caplets at bedtime

• do not take more than 2 caplets in 24 hours

• if taken w th food this product may take longer to work

Other information• read all warnings and directions

before use. Keep outer carton.

• each caplet contains: sodium 20 mg

• store at 20-25°C (68-77°F)

• avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients carnauba wax FD&C blue #2 aluminum lake hyprome lose magnesium stearate microcrysta line cellulose polyethylene glycol povidone purified water talc t tanium dioxide

Questions or comments? 1 800 395 0689 (Mon Fri 9AM 5PM EST)

40

ca

ple

ts*

CAPSULE-SHAPED TABLETS

Sl

ee

p A

id P

LU

S12

Ho

ur

Pa

in R

el

iev

ing

St

re

ng

th

of

Al

ev

e

®

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCl, 25 mg

Pain reliever/nighttime sleep-aid

Reference ID: 4151496

Page 9: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

XXXXXXXX

40

ca

plets

CAPSULE-SHAPED TABLETSSleep Aid

PLUS

12 Ho

ur

Pain R

elieving

Stren

gth

of Aleve

®

naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCI, 25 mgPain reliever/nighttime sleep-aid

SOFT G

RIP CA

OFT G

RIP CCCCA

Reference ID: 4151496

Page 10: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

XXXXXXXX

Do not use his p oduct if printed safety seal bearing “Bayer Heal hCare” under cap is torn or missing. See Carton For Fu l Information. Active ingredients (in each caplet) D phenhydram ne hydrochlor de 25 mg, Naproxen sod um 220 mg (nap oxen 200 mg) Warnings Allergy alert: Naproxen sodium may cause a severe a lerg c reaction, especially in people a lergic to asp rin Symptoms may nclude • h ves • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occu s, stop use and seek medical help

right away Stomach bleeding warning: This product contains an NSA D, which may cause severe stomach bleeding The chance is higher f you • are age 60 or older • have had stomach ulcers or bleeding p oblems • take a blood h nning (anticoagulant) or steroid drug • take o her drugs containing prescription or nonprescr pt on NSAIDs (aspi in, ibuprofen, naproxen, or others) • have 3 or more alcohol c dr nks every day wh le us ng this product • take more or for a longer t me han d rected Heart attack and stroke warning: NSA Ds, except aspir n, increase the risk of heart a tack, heart

fa lure, and stroke These can be fatal The risk is higher f you use more than directed or for longer than directed Do not use if you have ever had an allergic reaction to any other pain reliever fever reducer Ask a doctor or pharmacist before use if you are taking any other drug Stop use and ask a doctor if • you experience any of the follow ng signs of stomach bleed ng (feel faint, vomit blood, have bloody or black stools, have stomach pa n that does not get better), • you have symptoms of heart problems or stroke (chest pain, trouble

breathing, weakness in one part or side of body, slurred speech, leg swell ng) or pa n gets worse or lasts more than 10 days If pregnant or breast feeding, ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center r ght away Directions Do not take more than di ected. Adu ts and children 12 years and over take 2 caplets w th a full glass of water at bedtime Do not

take more than 2 caplets n 24 hours Questions or comments? 1 800 395 0689 (Mon Fri 9AM 5PM EST)

Bayer, the Bayer Cross and Aleve are registered trademarks of BayerDist by Bayer Heal hCare LLCWhippany, NJ 07981

Reference ID: 4151496

Page 11: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

Dist. by:Bayer HealthCare LLCW

hippany, NJ 07981M

ADE IN GERMANY

Bayer, the Bayer Cross, Aleve, and Soft Grip are registered tradem

arks of Bayer.

0000

XX

XX

XX

XX

Do not use this product if printed safety seal bearing“B

ayer HealthCare” under cap is torn or m

issing.

Drug Facts (continued)Do not use•

if you have ever had an allergic reaction to any other pain reliever/fever reducer

• in children under 12 years of age

• right before or after heart surgery

• with any other product containing diphenhydram

ine, even one used on skin

• if you have sleeplessness without pain

Ask a doctor before use if•

stomach bleeding warning applies to you

• you have problem

s or serious side effects from taking pain re

ievers or fever reducers

• you have a history of stom

ach problems, such as heartburn

• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthm

a, or had a stroke

• you are taking a diuretic

• you have a breathing problem

such as emphysem

a or chronic bronchitis

• you have glaucom

a

• you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers, or any other sleep-aid

•• taking any other antihistam

ines

• taking any other drug

When using this product

• drowsiness wil occur

• avoid alcoholic drinks

• do not drive a m

otor vehicle or operate machinery

• take with food or m

ilk f stomach upset occurs

Stop use and ask a doctor if•

you experience any of the following signs of stomach bleeding:

• feel faint •

vomit blood •

have bloody or black stools

• have stom

ach pain that does not get better

• you have sym

ptoms of heart problem

s or stroke:

• chest pain •

trouble breathing

• weakness in one part or side of body

• slurred speech •

leg swelling

Drug Facts (continued)

• pain gets worse or lasts m

ore than 10 days

• sleeplessness persists continuously for m

ore than 2 weeks. Insom

nia may be a sym

ptom of a serious underlying

medical illness.

• redness or swelling is present in the painful area

• any new sym

ptoms appear

• you have difficulty swallowing

• it feels lke the pil is stuck in your throat

If pregnant or breast-feeding, ask a health professional before use. It is especially im

portant not to use naproxen sodium during

the last 3 months of pregnancy unless definitely directed to do so

by a doctor because it may cause problem

s in the unborn chld or

complications during delivery.

Keep out of reach of children. In case of overdose, get medical

help or contact a Poison Control Center right away.

Directions•

do not take more than directed

• drink a full glass of water with each dose

• adults and children 12 years and over: take 2 caplets at bedtim

e

• do not take m

ore than 2 caplets in 24 hours

• if taken with food, this product m

ay take longer to work

Other information

• read all warnings and directions before use. Keep outer

carton.

• each caplet contains: sodium

20 mg

• store at 20-25ºC (68-77ºF)

• avoid high hum

idity and excessive heat above 40ºC (104ºF)

Inactive ingredients carnauba wax, FD&C blue #2 aluminum

lake, hyprom

ellose, magnesium

stearate, microcrystaline cellulose,

polyethylene glycol, povidone, purified water, talc, titanium dioxide

Questions or comm

ents? 1-800-395-0689

(Mon – Fri 9AM

– 5PM EST)

Drug FactsActive ingredients Purposes(in each caplet)Diphenhydram

ine hydrochloride 25 mg..........Nighttim

e sleep-aidNaproxen sodium

220 mg

(naproxen 200 mg) (NSAID)*.....................................Pain reliever

*nonsteroidal anti-inflamm

atory drug

Uses•

for relief of occasional sleeplessness when associated with m

inor aches and pains

• helps you fa

l asleep and stay asleep

Warnings

Allergy alert: Naproxen sodium m

ay cause a severe allergic reaction, especially in people allergic to aspirin. Sym

ptoms

may include:

• hives

• facial sweling

• asthm

a (wheezing)

• shock

• skin reddening •

rash •

blistersIf an allergic reaction occurs, stop use and seek m

edical help right away.Stom

ach bleeding warning: This product contains an NSAID, which m

ay cause severe stomach bleeding. The chance is

higher if you:

• are age 60 or older

• have had stom

ach ulcers or bleeding problems

• take a blood thinning (anticoagulant) or steroid drug

• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

• have 3 or m

ore alcohoic drinks every day while using

this product

• take m

ore or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use m

ore than directed or for longer than directed.

®

naroxen sodium

220 m NSAID)/

diphenhydramine HCI, 25 m

gPain reliever/nighttim

e sleep-aid

LOT/

EXP

40

ca

ple

tsCAPSULE-SHAPED TABLETS

®

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCI, 25 mg

Pain reliever/nighttime sleep-aid

PACKAGE IS CH

ILD-R

ESISTANT

Sl

ee

p A

id P

LU

S 12

Ho

ur

Pa

in R

el

iev

ing

St

re

ng

th

of

Al

ev

e

p(

))diphenhPain rel

®

SO

F

P C

AP

,g

hydramine HCI, 25 m

gliever/nighttim

e sleep-aid

TG

RIPPPPP

CA

®

LOT/

EXP

so

ft gr

ip C

AP

®

t gr

ip

pppCC

AP

®

Reference ID: 4151496

Page 12: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

CAPSULE-SHAPED TABLETS

®

XX

XX

XX

XX naproxen sodium

, 220 mg (NSAID)/

diphenhydramine HCI, 25 m

gPain reliever/nighttim

e sleep-aid

Sleep

Aid

PLU

S12 H

ou

r Pa

in R

elievin

gS

tren

gth

of A

leve

52 4

0 c

ap

lets*

Reference ID: 4151496

Page 13: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

LIFT

HERE

help right away. Stomach bleeding warning: This

product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if

you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning

(anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoho ic

drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except asprin, increase the risk of heart attack, heart

failure, and stroke. These can be fatal. The risk

is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor or pharmacist before use if you are taking any other drug If pregnant or breast-feeding, ask a health professional before use. Directions Do not take more than directed. Adu ts and children 12 years and over: take 2 caplets with a full glass of water at bedtime. Do not take more than 2 caplets in 24 hours. Questions or comments? 1-800-395-0689 (Mon-Fri 9AM – 5PM EST)Dist. by: Bayer HealthCare LLC, Whippany, NJ 07981

Do not use if foil sealimprinted with "SAFETY SQUEASE"

on bottle opening is missing or broken. See Carton For Full Information. Active ingredients (in

each caplet) Diphenhydramine hydrochloride 25 mg, Naproxen sodium 220 mg (naproxen 200 mg) Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives

• facial swelling • asthma (wheezing) • shock • skin reddening • rash

• blisters. If an allergic reaction occurs, stop use and seek medical XXXXXXXX

Reference ID: 4151496

Page 14: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

0000XXXXXXXX Do not use if carton is open or if foil seal imprinted with

"SAFETY SQUEASE" on bottle opening is missing or broken.

Dist. by:Bayer HealthCare LLCWhippany, NJ 07981MADE IN GERMANY

Safety Squease is a registeredtrademark of The Procter & GambleCompany. Used with permission.

Bayer, the Bayer Cross and Aleve areregistered trademarks of Bayer.

LOT/EXP

Drug FactsActive ingredients Purposes(in each caplet)Diphenhydraminehydrochloride 25 mg.........Nighttime sleep-aidNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)*.......Pain re iever*nonsteroidal anti-inflammatory drug

Uses • for relief of occasional sleeplessness when

associated with minor aches and pains• helps you fall asleep and stay asleep

WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock• skin reddening • rash • blistersIf an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher f you:• are age 60 or older• have had stomach ulcers or bleeding

problems• take a blood thinning (anticoagulant) or

steroid drug• take other drugs containing prescription or

nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

• have 3 or more alcoholic drinks every day while using this product

• take more or for a longer time than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Drug Facts (continued)Do not use• f you have ever had an allergic reaction to any other pain

reliever/fever reducer•• in children under 12 years of age• right before or after heart surgery• w th any other product containing diphenhydramine, even

one used on skin• f you have sleeplessness without painAsk a doctor before use if• stomach bleeding warning app ies to you• you have problems or serious side effects from taking pain

relievers or fever reducers• you have a history of stomach problems, such as heartburn• you have high blood pressure, heart disease, iver cirrhosis,

kidney disease, asthma, or had a stroke• you are taking a diuretic• you have a breathing problem such as emphysema or

chronic bronchitis• you have glaucoma• you have trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are• taking sedatives or tranquilizers, or any other sleep-aid•• taking any other antihistamines• taking any other drugWhen using this product• drowsiness will occur• avoid alcoholic drinks• do not drive a motor vehicle or operate machinery• take with food or milk if stomach upset occursStop use and ask a doctor if• you experience any of the following signs of stomach bleeding:

• feel faint • vom t blood • have bloody or black stools• have stomach pain that does not get better

• you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body• slurred speech • leg swe ling

• pain gets worse or lasts more than 10 days• sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of a serious underlying medical illness.

Drug Facts (continued)• redness or swelling is present in the

painful area• any new symptoms appear• you have difficulty swallowing• it feels like the pill is stuck in your throatIf pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn ch ld or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions • do not take more than directed• drink a full glass of water with each dose• adults and children 12 years and over:

take 2 caplets at bedtime• do not take more than 2 caplets in

24 hours• if taken with food, this product may take

longer to work

Other information • read all warnings and directions before use. Keep outer carton.• each caplet contains: sodium 20 mg• store at 20-25°C (68-77°F) • avoid high humidity and excessive heat

above 40°C (104°F)

Inactive ingredients carnauba wax, FD&C blue #2 aluminum lake, hyprome lose, magnesium stearate, microcrysta line cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide

Questions? 1-800-395-0689

40

ca

ple

ts*

CAPSULE-SHAPED TABLETS

®524

0 c

ap

lets

*CAPSULE-SHAPED TABLETS

®52

Sle

ep

Aid

PLU

S12

Ho

ur

Pa

in R

elie

vin

gS

tre

ng

th o

f Ale

ve

Sle

ep

Aid

PLU

S12

Ho

ur

Pa

in R

elie

vin

gS

tre

ng

th o

f Ale

ve

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCI, 25 mg

Pain reliever/nighttime sleep-aid

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCI, 25 mg

Pain reliever/nighttime sleep-aid

FREEFREECAPLETSCAPLETS

PURCHASEWITH THIS

1212

Reference ID: 4151496

Page 15: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

80

ca

plets

*CAPSULE-SHAPED TABLETS

Sle

ep

Aid

PLU

S12

Ho

ur

Pa

in R

elie

vin

gS

tre

ng

th o

f Ale

ve

XX

XX

XX

XX

®

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCI, 25 mg

Pain reliever/nighttime sleep-aid

Reference ID: 4151496

Page 16: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

Made n Germ

anyD

st by Bayer HeathCare LLCW

hppany NJ 07981

Bayer the Bayer Cross and A

eve are regs

eed tradem

arks of Bayer

XXXXXXXX

Do not use if foil seal im

printed wih “SAFETY SQUEASE” on botle

opening is missing or broken.

See Carton For Full Information.

Active ngredients (in each caplet) D

phenhydramne hyd

ochorde 25 mg, Naproxen

sodum 220 m

g (naproxen 200 mg) W

arnngs Allergy

alert: Naproxen sodum m

ay cause a severe aergc

reacton, especay n peope a

ergc to asprn. Symptom

s m

ay ncude: • hves •

faca sweng •

asthma

(wheezng) • shock •

skn reddenng • rash

• b

sers. If an aergc reacton occurs, stop use and seek

medca hep rght away. Stom

ach bleeding warning: Ths p

oduct contans an NSAID, whch may cause severe

stomach beedng. The chance s hgher f you: •

are age 60 or oder •

have had stomach ucers or beedng

pobem

s • take a bood hnnng (antcoaguant) or sterod

drug • ake o

her drugs contanng prescrpton or nonprescrpton NSA

Ds (asprn, buprofen,

naproxen, or others) •

have 3 or m

ore acohoc drnks every

day whe usng ths product

• take m

ore or for a onger tme

han drected Heart attack and stroke warning: NSAIDs, except

asprn, ncrease the rsk of heart attack, heart fa

ure, and stoke. These can be fata. The rsk s hgher f you use m

ore than drected or for onger than drected. Do not use f you have ever had an a

ergc reacton to any oher pan

reever/fever reducer Ask a doctor or

pharmacist before use if you are takng

any other drug Stop use and ask a doctor if •

you experence any of the fo

owng sgns of stom

ach beedng: (fee fant, vom

t bood, have boody or back stoos, have stom

ach pan hat does not get be

te) •

you have symptom

s of heart

probems or stroke

(chest pan, troube breathng, weakness n one part or sde of body, surred speech, eg swe

ng) or pan gets worse or asts m

oe han

10 days If pregnant or breast-feeding, ask a hea

h professona before use. D

rections Do not take more than

directed. Aduts and chdren 12 years

and over: take 2 capets wth a fu

gass of water at bedtm

e. Do not ake more than 2

capets n 24 hours. Questions or com

men

s? 1800-395-0689 (M

on-Fr 9AM

- 5PM EST)

LIFT

HER

E

Reference ID: 4151496

Page 17: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

Drug FactsActive ingredients Purposes(in each caplet)Diphenhydramine hydrochloride 25 mg ......Nighttime sleep-aidNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)*.....Pain re iever*nonsteroidal anti-inflammatory drug

Uses• for relief of occasional sleeplessness

when associated w th minor aches and pains

• helps you fall asleep and stay asleep

WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives • facial swelling

• asthma (wheezing) • shock

• skin reddening • rash

• blistersIf an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older

• have had stomach ulcers or bleeding problems

• take a blood thinning (anticoagulant) or steroid drug

• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

• have 3 or more alcoholic drinks every day while using this product

• take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Drug Facts (continued)Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer

•• in children under 12 years of age

• right before or after heart surgery

• with any other product containing diphenhydramine, even one used on skin

• if you have sleeplessness without painAsk a doctor before use if

• stomach bleeding warning applies to you

• you have problems or serious side effects from taking pain relievers or fever reducers

• you have a history of stomach problems, such as heartburn

• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

• you are taking a diuretic

• you have a breathing problem such as emphysema or chronic bronchitis

• you have glaucoma

• you have trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers, or any other sleep-aid

•• taking any other antihistamines

• taking any other drugWhen using this product

• drowsiness will occur

• avoid alcoholic drinks

• do not drive a motor vehicle or operate machinery

• take with food or milk if stomach upset occursStop use and ask a doctor if

• you experience any of the following signs of stomach bleeding:

• feel faint • vomit blood • have bloody or black stools

• have stomach pain that does not get better

• you have symptoms of heart problems or stroke:

• chest pain • trouble breathing

• weakness in one part or side of body

• slurred speech • leg swelling

• pain gets worse or lasts more than 10 days

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

• redness or swelling is present in the painful area

• any new symptoms appear

• you have difficulty swallowing

• it feels like the p ll is stuck in your throat

Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because t may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions• do not take more than directed

• drink a fu l glass of water with each dose

• adults and children 12 years and over: take 2 caplets at bedtime

• do not take more than 2 caplets in 24 hours

• if taken with food, this product may take longer to work

Other information• read all warnings and directions

before use. Keep outer carton.

• each caplet contains: sodium 20 mg

• store at 20-25°C (68-77°F)

• avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients carnauba wax, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide

Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

Dist. by:Bayer HealthCare LLCWhippany, NJ 07981MADE IN GERMANY

Do not use if carton is open or if foil seal imprinted with "SAFETY SQUEASE" on bottle opening is missing or broken.

Safety Squease is a registeredtrademark of The Procter & GambleCompany. Used with permission.

XXXXXXXX

0000

Bayer, the Bayer Cross and Aleve areregistered trademarks of Bayer.

LOT/EXP

80

ca

ple

ts*

CAPSULE-SHAPED TABLETS

Sl

ee

p A

id P

LU

S12

Ho

ur

Pa

in R

el

iev

ing

St

re

ng

th

of

Al

ev

e

®

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCl, 25 mg

Pain reliever/nighttime sleep-aid

Reference ID: 4151496

Page 18: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

XXXXX

LOT

EXP

Do not use if carton is open or if foil seal im

printed with

"SAFETY SQ

UEA

SE" on bottle opening is missing or broken.

Bayer the Bayer Cross and Aleveare registered tradem

arks of Bayer.

Dist. byBayer Hea

thCare LLCW

hppany NJ 07981

MADE IN GERM

ANY

Safety Squease is a registeredtradem

ark of The Procter & Gam

bleCom

pany. Used with perm

ission.

Drug FactsActive ingredients Purposes(in each caplet)Diphenhydraminehydrochloride 25 mg..... ..Night ime sleep-aidNaproxen sodium 220 mg(naproxen 200 mg) (NSAID)* .....Pain re iever*nonsteroidal anti-inflammatory drug

Uses • for re ief of occasional sleeplessness

when associated w th minor achesand pains

• helps you fall as eep and stay as eep

WarningsAllergy alert: Naproxen sodium may causea severe allergic reaction especially in people allerg c to aspirin. Symptoms may include• hives • facial swelling • asthma (wheezing) • shock• skin reddening • rash• bl stersIf an allergic reaction occurs stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance is higher f you• are age 60 or older• have had stomach ulcers or bleeding problems• take a blood thinning (anticoagulant) or steroid drug• take other drugs containing prescription or nonprescr ption NSAIDs (aspirin buprofen naproxen or others)• have 3 or more alcohol c drinks every day wh le using this product• take more or for a longer time than directed

Drug Facts (continued)Heart attack and stroke warning: NSAIDs except aspirin increase the r sk of heart attack heart failure and stroke. These can be fatal. The risk s h gher if you use more than directed or for longer than directed.Do not use• f you have ever had an allergic reaction to any other pain

reliever/fever reducer•• in children under 12 years of age• r ght before or after heart surgery• with any other product containing d phenhydramine even

one used on skin• f you have sleeplessness without painAsk a doctor before use if• stomach bleeding warning applies to you• you have problems or serious s de effects from taking pain

relievers or fever reducers• you have a h story of stomach problems such as heartburn• you have high blood pressure heart d sease liver cirrhos s

kidney disease asthma or had a stroke• you are taking a diuretic• you have a breathing problem such as emphysema or

chron c bronchitis• you have glaucoma• you have trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are• taking sedat ves or tranquilizers or any other sleep-a d•• taking any other antihistamines• taking any other drugWhen using this product• drowsiness will occur• avoid alcoholic drinks• do not drive a motor vehicle or operate machinery• take w th food or milk if stomach upset occursStop use and ask a doctor if• you experience any of the ol owing signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better

Drug Facts (continued)• you have symptoms of heart problems or stroke:

• chest pain • trouble breathing• weakness in one part or side of body • slurred speech • leg swel ing

• pain gets worse or lasts more than 10 days• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious under ying medical illness. • redness or swel ing is present in the painful area• any new symptoms appear• you have difficulty swa lowing• t feels like the pi l is stuck in your throatIf pregnant or breast-feeding, ask a hea th professional before use. It s especia ly important not to use naproxen sodium during the last 3 months of pregnancy unless defin tely directed to do so by a doctor because t may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose get med cal help or contact a Poison Control Center right away.

Directions• do not take more than directed• drink a fu l glass of water with each dose• adu ts and children 12 years and over: take 2 caplets at bedtime• do not take more than 2 cap ets in 24 hours• if taken with food, this product may take onger to work

Other information• read all warnings and directions before use. Keep outer

carton.• each caplet contains: sodium 20 mg• store at 20-25ºC (68-77ºF) • avoid high humidity and excessive heat above 40ºC (104ºF)

Inactive ingredients carnauba wax, FD&C blue #2 aluminum lake, hyprome lose, magnesium stearate, microcrysta line cellu ose, po yethy ene glycol, povidone, purified water, talc, itanium dioxide

Questions or comments? 1-800-395-0689(Mon – Fri 9AM – 5PM EST)

®

naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCI, 25 mgPain reliever/nighttime sleep-aid

®

Sleep Aid PLUS12 Hour Pain RelievingStrength of Aleve

naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCI, 25 mgPain reliever/nighttime sleep-aid

wheand

• hel

WarnAllerga sevepeopleinclude• hive• asth• skin• bl sIf an aseek mStomacontainstomac• are• hav pro• tak ste• tak or bu• hav

wh

®

Sleep Aid PLUS12 Hour Pain Relieving12 Hour Pain RelievingStrength of Aleve

naproxen sodium, 220 mg (NSAID)/ ))diphenhydramine HCI, 25 mgPain reliever/nighttime sleep-aid

160 caplets* *CAPSULE-SHAPED TABLETS

two 80-count bottles inside

Reference ID: 4151496

Page 19: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

80

ca

plets

**CAPSULE-SHAPED TABLETS

Sle

ep

Aid

PLU

S12

Ho

ur

Pa

in R

elie

vin

gS

tre

ng

th o

f Ale

ve

XX

XX

XX

XX

®

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCI, 25 mg

Pain reliever/nighttime sleep-aid

96

Reference ID: 4151496

Page 20: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

Made n Germ

anyD

st by Bayer HeathCare LLCW

hppany NJ 07981

Bayer the Bayer Cross and A

eve are regs

eed tradem

arks of Bayer

XXXXXXXX

Do not use if foil seal im

printed wih “SAFETY SQUEASE” on botle

opening is missing or broken.

See Carton For Full Information.

Active ngredients (in each caplet) D

phenhydramne hyd

ochorde 25 mg, Naproxen

sodum 220 m

g (naproxen 200 mg) W

arnngs Allergy

alert: Naproxen sodum m

ay cause a severe aergc

reacton, especay n peope a

ergc to asprn. Symptom

s m

ay ncude: • hves •

faca sweng •

asthma

(wheezng) • shock •

skn reddenng • rash

• b

sers. If an aergc reacton occurs, stop use and seek

medca hep rght away. Stom

ach bleeding warning: Ths p

oduct contans an NSAID, whch may cause severe

stomach beedng. The chance s hgher f you: •

are age 60 or oder •

have had stomach ucers or beedng

pobem

s • take a bood hnnng (antcoaguant) or sterod

drug • ake o

her drugs contanng prescrpton or nonprescrpton NSA

Ds (asprn, buprofen,

naproxen, or others) •

have 3 or m

ore acohoc drnks every

day whe usng ths product

• take m

ore or for a onger tme

han drected Heart attack and stroke warning: NSAIDs, except

asprn, ncrease the rsk of heart attack, heart fa

ure, and stoke. These can be fata. The rsk s hgher f you use m

ore than drected or for onger than drected. Do not use f you have ever had an a

ergc reacton to any oher pan

reever/fever reducer Ask a doctor or

pharmacist before use if you are takng

any other drug Stop use and ask a doctor if •

you experence any of the fo

owng sgns of stom

ach beedng: (fee fant, vom

t bood, have boody or back stoos, have stom

ach pan hat does not get be

te) •

you have symptom

s of heart

probems or stroke

(chest pan, troube breathng, weakness n one part or sde of body, surred speech, eg swe

ng) or pan gets worse or asts m

oe han

10 days If pregnant or breast-feeding, ask a hea

h professona before use. D

rections Do not take more than

directed. Aduts and chdren 12 years

and over: take 2 capets wth a fu

gass of water at bedtm

e. Do not ake more than 2

capets n 24 hours. Questions or com

men

s? 1800-395-0689 (M

on-Fr 9AM

- 5PM EST)

LIFT

HER

E

Reference ID: 4151496

Page 21: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

Drug FactsActive ingredients Purposes(in each caplet)Diphenhydramine hydrochloride 25 mg.......Nighttime sleep-aidNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)*.....Pain re iever*nonsteroidal anti-inflammatory drug

Uses • for relief of occasional sleeplessness

when associated with minor aches and pains

• helps you fall asleep and stay asleep

WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives • facial swelling

• asthma (wheezing) • shock

• skin reddening • rash

• blistersIf an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older

• have had stomach ulcers or bleeding problems

• take a blood thinning (anticoagulant) or steroid drug

• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

• have 3 or more alcoholic drinks every day while using this product

• take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher f you use more than directed or for longer than directed.

Drug Facts (continued)Do not use

• f you have ever had an allergic reaction to any other pain reliever/fever reducer

•• in children under 12 years of age

• right before or after heart surgery

• w th any other product containing diphenhydramine, even one used on skin

• f you have sleeplessness without painAsk a doctor before use if

• stomach bleeding warning app ies to you

• you have problems or serious side effects from taking pain relievers or fever reducers

• you have a history of stomach problems, such as heartburn

• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

• you are taking a diuretic

• you have a breathing problem such as emphysema or chronic bronchitis

• you have glaucoma

• you have trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers, or any other sleep-aid

•• taking any other antihistamines

• taking any other drugWhen using this product

• drowsiness will occur

• avoid alcoholic drinks

• do not drive a motor vehicle or operate machinery

• take with food or milk if stomach upset occursStop use and ask a doctor if

• you experience any of the fo lowing signs of stomach bleeding:

• feel faint • vomit blood • have bloody or black stools

• have stomach pain that does not get better

• you have symptoms of heart problems or stroke:

• chest pain • trouble breathing

• weakness in one part or side of body

• slurred speech • leg swel ing

• pain gets worse or lasts more than 10 days

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

• redness or swe ling is present in the painful area

• any new symptoms appear

• you have difficulty swallowing

• it feels like the pill is stuck in your throat

Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions • do not take more than directed

• drink a fu l glass of water with each dose

• adults and children 12 years and over: take 2 caplets at bedtime

• do not take more than 2 caplets in 24 hours

• if taken with food, this product may take longer to work

Other information • read all warnings and directions

before use. Keep outer carton.

• each caplet contains: sodium 20 mg

• store at 20-25°C (68-77°F)

• avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients carnauba wax, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystal ine cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide

Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

Dist. by:Bayer HealthCare LLCWhippany, NJ 07981MADE IN GERMANY

Do not use if carton is open or if foil seal imprinted with "SAFETY SQUEASE" on bottle opening is missing or broken.

Safety Squease is a registeredtrademark of The Procter & GambleCompany. Used with permission.

XXXXXXXX

0000

Bayer, the Bayer Cross and Aleve areregistered trademarks of Bayer.

LOT/EXP

80

ca

ple

ts*

*CAPSULE-SHAPED TABLETS

968

0 c

ap

lets

**CAPSULE-SHAPED TABLETS

96

®®

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCI, 25 mg

Pain reliever/nighttime sleep-aid

naproxen sodium, 220 m

g (NSAID)/ diphenhydram

ine HCI, 25 mg

Pain reliever/nighttime sleep-aid

Sl

ee

p A

id P

LU

S12

Ho

ur

Pa

in R

el

iev

ing

St

re

ng

th

of

Al

ev

e

Sl

ee

p A

id P

LU

S12

Ho

ur

Pa

in R

el

iev

ing

St

re

ng

th

of

Al

ev

e

FREEFREECAPLETSCAPLETS

PURCHASEWITH THIS

1616

Reference ID: 4151496

Page 22: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

XXXXXXXX

EAS

Y O

PEN C

AP

Reference ID: 4151496

Page 23: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

Made in Germany

Dist byBayer Heal hCare LLCWhippany, NJ 07981

Bayer, the Bayer Cross, and Aleve are registered trademarks of Bayer

XXXXXXXX

Do not use this product if printed safety seal bearing “Bayer HealthCare” under cap is torn or missing.

i ( h Diphenhydramine hydrochloride 25 mg ... ... ... Night ime sleep aidNaproxen sodium 220 mg (naproxen 200 mg)(NSAID)* . ... ... ... ... ... ... ... .... ... .Pain re iever*nonste oidal an i-inflamma ory drug

• for

reef

of o

ccas

ona

see

pes

snes

s wh

en a

ssoc

ated

w

h m

nor a

ches

and

pa

ns

• he

ps y

ou fa

ase

ep a

nd s

tay

asee

p

gAl

lerg

y al

ert:

Napr

oxen

sod

um m

ay c

ause

a s

ever

e a

erg

c re

acto

n, e

spec

ay

n pe

ope

aer

gc

to a

sprn

. Sy

mpt

oms

may

ncu

de:

• hve

s • f

aca

swe

ng

• ast

hma

(whe

ezng

) • s

hock

• skn

redd

enng

• r

ash

• bst

es

If an

aer

gc

reac

ton

occu

rs, s

top

use

and

seek

med

ca

hep

rght

awa

y.St

omac

h bl

eedi

ng w

arni

ng: T

hs

prod

uct c

onta

ns a

n NS

AID,

wh

ch m

ay c

ause

sev

ere

stom

ach

beed

ng. T

he

chan

ce s

hgh

er f

you:

• are

age

60

or o

der

• hav

e ha

d st

omac

h u

cers

or b

eed

ng p

robe

ms

• tak

e a

bood

thnn

ng (a

ntco

agu

ant)

or s

tero

d dr

ug

• tak

e o

her d

rugs

con

tan

ng p

resc

rpto

n or

no

npre

scrp

ton

NSAI

Ds (a

sprn

, bu

prof

en, n

apro

xen,

or

ohe

rs)

• hav

e 3

or m

ore

aco

hoc

drnk

s ev

ery

day

whe

usng

h

s pr

oduc

t

• tak

e m

ore

or fo

r a o

nger

tm

e ha

n d

rect

edHe

art a

ttack

and

stro

ke w

arni

ng: N

SAID

s, ex

cept

as

prn

, nc

reas

e th

e rs

k of

hea

rt at

tack

, hea

rt fa

ure,

and

st

roke

. The

se c

an b

e fa

ta. T

he r

sk s

hgh

er f

you

use

mor

e th

an d

ecte

d or

for

onge

r tha

n d

rect

ed.

• f y

ou h

ave

ever

had

an

aer

gc

reac

ton

to a

ny o

ther

pa

n re

eve

/feve

r red

ucer

• un

ess

you

have

tm

e fo

r a fu

ngh

ts s

eep

• n

chdr

en u

nder

12

year

s of

age

• rgh

t bef

ore

or a

fter h

eart

surg

ery

• wth

any

oth

er p

rodu

ct c

onta

nng

dph

enhy

dram

ne,

even

one

use

d on

skn

• f y

ou h

ave

seep

essn

ess

wth

out p

an

• sto

mac

h be

edng

war

nng

app

es to

you

• you

hav

e pr

obem

s or

ser

ous

sde

effe

cts

from

takn

g pa

n re

ever

s or

feve

r red

ucer

s

• you

hav

e a

hst

ory

of s

tom

ach

prob

ems,

such

as

hear

tbur

n

• you

hav

e h

gh b

ood

pres

sure

, hea

rt d

seas

e, v

er

crrh

oss,

kdne

y d

seas

e, a

sthm

a, o

r had

a s

troke

• you

are

takn

g a

dur

etc

• you

hav

e a

brea

thng

pro

bem

suc

h as

em

phys

ema

or c

hron

c br

onch

ts

• you

hav

e g

auco

ma

• you

hav

e tro

ube

urna

tng

due

to a

n en

arge

d pr

osta

te g

and

• tak

ng se

datv

es o

r tra

nqu

zers

, or a

ny o

ther

see

p-ad

• und

er a

doc

tors

car

e fo

r any

ser

ous

cond

ton

• tak

ng a

ny o

ther

ant

hst

amne

s

• tak

ng a

ny o

ther

dru

g

• dro

wsne

ss w

occ

ur

• avo

d a

coho

c dr

nks

• do

not d

rve

a m

otor

veh

ce o

r ope

rate

mac

hne

ry

• tak

e w

h fo

od o

r mk

f sto

mac

h up

set o

ccur

s

• you

exp

eren

ce a

ny o

f the

foow

ng s

gns

of s

tom

ach

beed

ng:

• fee

fant

• v

omt b

ood

• hav

e bo

ody

or b

ack

stoo

s

• hav

e st

omac

h pa

n th

at d

oes

not g

et b

ette

r

• you

hav

e sy

mpt

oms

of h

eart

pob

ems

or s

troke

:

• che

st p

an

• t

roub

e br

eath

ng

• wea

knes

s n

one

part

or s

de o

f bod

y

• sur

red

spee

ch

• eg

swe

ng

• pa

n ge

ts w

orse

or

asts

mor

e th

an 1

0 da

ys

• che

st p

an

• see

pes

snes

s pe

rsst

s co

ntnu

ousy

for m

ore

than

2

wee

ks. I

nsom

na

may

be

a sy

mpt

om o

f a s

erou

s un

dery

ng m

edca

ne

ss.

• red

ness

or s

weng

s p

rese

nt n

the

panf

u a

rea

• any

new

sym

ptom

s ap

pear

• you

hav

e d

ffcu

ty sw

aow

ng

• t f

ees

ke th

e p

s s

tuck

n yo

ur th

roat

a

sk a

hea

th p

rofe

sson

a

befo

re u

se.

It s

espe

cay

mpo

rtant

not

to u

se n

apro

xen

sod

um d

urng

the

ast 3

mon

hs o

f pre

gnan

cy u

nes

s de

fnte

y d

rect

ed to

do

so b

y a

doct

or b

ecau

se t

may

ca

use

prob

ems

n he

unb

orn

chd

or c

omp

cato

ns

durn

g de

very.

Keep

out

of r

each

of c

hld

ren.

In

case

of o

verd

ose,

get

m

edca

hep

or c

onta

ct a

Poso

n Co

ntro

Cen

ter r

ght a

way.

• do

not t

ake

mor

e th

an d

irect

ed

• drn

k a

fu g

ass

of w

ater

wth

eac

h do

se

• adu

ts a

nd c

hdr

en 1

2 ye

ars

and

over

: tak

e 2

cap

ets

at b

edtm

e

• do

not t

ake

mor

e th

an 2

cap

ets

n 24

hou

rs

• f ta

ken

wth

food

, ths

pro

duct

may

take

ong

er to

wor

k

h

• rea

d al

l war

ning

s an

d di

rect

ions

bef

ore

use.

• eac

h ca

plet

con

tain

s: s

odum

20

mg

• sto

re a

t 20-

25°C

(68-

77°F

)

• avo

d h

gh h

umd

ty a

nd e

xces

sve

heat

abo

ve

40°C

(104

°F)

c

arna

uba

wax,

FD&

C b

ue

#2 a

umnu

m a

ke, h

ypro

me

ose,

mag

nesu

m s

tear

ate,

m

croc

ryst

ane

ce

uos

e, p

oye

thye

ne g

yco

, pov

done

, pu

rfed

wat

er, t

ac,

tta

num

dox

de

(Mon

-Fr

9AM

– 5

PM E

ST) Drug Facts

Drug

Fac

ts (c

ontin

ued)

Drug

Fac

ts (c

ontin

ued)

Reference ID: 4151496

Page 24: Reference ID: 4151496 · 2017. 9. 13. · 20 caplets* CAPSULE-SHAPED TABLETS ® XX X XXXXX naproxen sodium, 220 mg (NSAID) / diphenhydramine HCI, 25 mg Pain reliever/nighttime sleep-aid

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

VALERIE S PRATT09/12/2017

Reference ID: 4151496

(