reference id: 4151496 · 2017. 9. 13. · 20 caplets* capsule-shaped tablets ® xx x xxxxx naproxen...
TRANSCRIPT
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
®
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
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
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Reference ID: 4151496
LIFT
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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
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
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*CAPSULE-SHAPED TABLETS
Sle
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Aid
PLU
S12
Ho
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Pa
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naproxen sodium, 220 m
g (NSAID)/ diphenhydram
ine HCI, 25 mg
Pain reliever/nighttime sleep-aid
Reference ID: 4151496
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
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
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
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ts*
CAPSULE-SHAPED TABLETS
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id P
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S12
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naproxen sodium, 220 m
g (NSAID)/ diphenhydram
ine HCl, 25 mg
Pain reliever/nighttime sleep-aid
Reference ID: 4151496
XXXXXXXX
40
ca
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CAPSULE-SHAPED TABLETSSleep Aid
PLUS
12 Ho
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naproxen sodium, 220 mg (NSAID)/ diphenhydramine HCI, 25 mgPain reliever/nighttime sleep-aid
SOFT G
RIP CA
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OFT G
RIP CCCCA
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Reference ID: 4151496
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
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.
®
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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
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
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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
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naproxen sodium, 220 m
g (NSAID)/ diphenhydram
ine HCI, 25 mg
Pain reliever/nighttime sleep-aid
Reference ID: 4151496
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
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
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
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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
80
ca
plets
**CAPSULE-SHAPED TABLETS
Sle
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XX
XX
XX
XX
®
naproxen sodium, 220 m
g (NSAID)/ diphenhydram
ine HCI, 25 mg
Pain reliever/nighttime sleep-aid
96
Reference ID: 4151496
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
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
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ap
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**CAPSULE-SHAPED TABLETS
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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
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Reference ID: 4151496
XXXXXXXX
EAS
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Reference ID: 4151496
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
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w
h m
nor a
ches
and
pa
ns
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ps y
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ert:
Napr
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ause
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ever
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erg
c re
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spec
ay
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ope
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sprn
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mpt
oms
may
ncu
de:
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s • f
aca
swe
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• 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
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omac
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eedi
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arni
ng: T
hs
prod
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onta
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n NS
AID,
wh
ch m
ay c
ause
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ere
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ach
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he
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ce s
hgh
er f
you:
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age
60
or o
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• hav
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d st
omac
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cers
or b
eed
ng p
robe
ms
• tak
e a
bood
thnn
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ntco
agu
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or s
tero
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ug
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her d
rugs
con
tan
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resc
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n or
no
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scrp
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NSAI
Ds (a
sprn
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prof
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apro
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or
ohe
rs)
• hav
e 3
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ery
day
whe
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oduc
t
• tak
e m
ore
or fo
r a o
nger
tm
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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
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rt fa
ure,
and
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roke
. The
se c
an b
e fa
ta. T
he r
sk s
hgh
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you
use
mor
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ecte
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for
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ave
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ess
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nder
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year
s of
age
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t bef
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• wth
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even
one
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skn
• f y
ou h
ave
seep
essn
ess
wth
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an
• sto
mac
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edng
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app
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you
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hav
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obem
s or
ser
ous
sde
effe
cts
from
takn
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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
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gh b
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pres
sure
, hea
rt d
seas
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er
crrh
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kdne
y d
seas
e, a
sthm
a, o
r had
a s
troke
• you
are
takn
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dur
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• you
hav
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brea
thng
pro
bem
suc
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em
phys
ema
or c
hron
c br
onch
ts
• you
hav
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auco
ma
• you
hav
e tro
ube
urna
tng
due
to a
n en
arge
d pr
osta
te g
and
• tak
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datv
es o
r tra
nqu
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, or a
ny o
ther
see
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• 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
---------------------------------------------------------------------------------------------------------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
(