aspirin ' xq j - food and drug administration · no print glue area drug facts (continued} •...
TRANSCRIPT
FRONT SIDE
· Drug Fa-cts------------: I
Active ingredient Purpose 1
(in each capsule) Aspirin (NSA!D)* 325mg ... Pain re liever/fever reducer *nonsteroida l anb-inflammatorydrug
Uses • forthetemporaryrel lefofminorachesandpains
associated with: • a cold • headache • backache • toothache •premenstrual&menstrualcramps •minorpainofarthritis
• temporarily reduces fever
Warnings Reye's syndrome: Child ren and teenagers who have or arerecoveringfromchickenpoxorftu-likesymptoms shouldnotusethisproduct. Whenusingthisproduct, if changesinbehaviorwith nausea and vomiting occur, consultadoctorbecausethesesymptomscouldbean earlys1gn ofReye'ssyndrome, a rare but serious illness.
+ Continue Reading ~~ ------------------1 Drug Facts (continued)
Allergy alert: Aspirin may cause a severe allergic reactionwhichmayinclude: • hives • facial swell ing • shock • asthma (wheezing) This product contams soy.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher 1fyou: • are age 60 or older
"-' • have had stomach ulcers or bleeding problems a- • takeabloodthinning(anticoagulant)orsteroiddrug ~ • takeotherdrugscontainingprescriptionor
"-'
nonprescription NSA!Ds [aspirin, ibuprofen, naproxen, orothers] 1
• have 3 ormorea lcoholicdrinkseverydaywhileusing 1
this product • takemoreorforalongertimethandirected
Do not use if you have ever had an allergic reaction to aspirin or any other pam rel1ever/fever reducer.
Ask a doctor before use if • stomach bleedingwarningappliestoyou
_I_ - - - - - - - - - - - - - - - - -
Drug Facts (continued) • youhaveahistoryof stomachproblems,suchas
heartburn • you have high blood pressure, heart disease,
liver cirrhosis, or kidney disease • youaretakingadiuretic • you have asthma
Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout or
arthritis
a- Stop use and ask doctor if ~ • an allergic reation occurs. Seek medical help
right away. • you experience any of the following signs of
stomach bleeding: • feel fa int • vomit blood • have bloody or black stools •have stomach painthatdoesnotgetbetter
• paingetsworseorlastsmorethan10days • fevergetsworseor lastsformore than ldays
1 • nngmg in the ears or loss of hearing occurs
+
BACKSIDE
r----------------- -I
: Drug Facts (contin ued) 1 • rednessorswellmg is present in the painful area : • any new symptoms occur. These could be signs of a 1
1 seriouscondltion. 1 If pregnant or breast-feeding, ask a health care 1
: professional before use. It IS especially important not 1 touseasp~rmdunngthe lastlmonthsofpregnancy 1 unless definitely directed to do so by a doctor because 1 1tmaycause problems in the unborn chi ld or I complicationsduringdelivery.
"-' 1 Keep out of reach of children. In case of overdose, 1
a- : consultadoctorgetmedical help or contact a Poison ~ 1 ControiCenterrightaway.
1 Directions 1 • drinkafullglassofwaterwitheachdose 1 • adultsandchildren12yearsandover:
• take 1 or 2 capsules every4 hours or 3 capsules every 6 hours whi le symptoms persist
• do not exceed 12 capsules in 24 hours 1 • childrenunder12years:consultadoctor
I + I J __________________ 1
: Drug Facts (continued)
: Other information 1 • save carton for fu ll directions and warnings I • store at 15- JO'C (59- 86'F) 1 • avoid excessive heat above 40'C (104'F)
• do not use if the blue band around the capsule 1s missing or broken
1 Inactive ingredients anhydrous c1tric acid, 1
I carrageenan, col loidal silicon dioxide, FD&C Blue #1, "-' : hypromellose,mediumchaintriglycerides, a- 1 pharmaceutical ink, potassiumchlonde,soylecithin, ~ 1 titaniumdioxide
I
: Questions or comments
: Call1·800·123·4567 8:30AM -4:00PM ET, 1 Monday- Friday
I _ , _ - - - - - - - - - - - - - - - - - -1
Plx Pharma Inc. 8285 El Rio, Suite 130
Houston, TX 77054
Tel: 713·842·1249
Fax: 713-842-3052
Distributed by: Company XXX
Visit us at www.companyxxx.com
NDCI:1234-5678-90
ASPIRIN Aspirin Capsules, 325mg Pain Reliever I Fever Reducer (NSAID}
Fold Out Panel
TAMPER EVIOENTo 00 NOT USE IF IMPRINTEO SAFETY SEAl WITH REPEATED TEXT "SEALED FOR YOUR PROTECTION" UNDER CAP IS MISSING OR BROKEN.
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Reference ID: 3244430Reference ID: 3244833
No Print Glue Area
Drug Facts (continued}
• have had stomach ulcers or bleeding problems • lake a blood lhinn1ng (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 •lake more or for a longer lime than directed
Do not use if you have ever had an al lergic reaction to aspirin or any other pain rel iever/fever reducer.
Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or
k1dney d1sease • you are taking a diuretic • you have asthma
Ask a doctor or pharmacist before use if you are • tak1ng a prescription drug for diabetes, gout or arthritis
Stop use and ask doctor if • an allergic reation occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding:
• feel faint • vom1l blood • have bloody or black stools • have stomach pain that does not get betler
• pain gets worse or lasts more than 10 days • fever gets worse or lasts for more than 3 days • ringing 1n the ears or loss of hearing occurs • redness or swell ing is present in the painful area • any new symptoms occur. These could be signs of a
serious conditiOn.
No Print Glue Area
Directions • drink a full glass of water with each dose • adults and ch ildren 12 years and over:
• take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist
• do not exceed 12 capsules in 24 hours • children under 12 years: consult a doctor
Other information • save carton for full directions and warnings • store at 15 · 30"C (59 · 86"~ • avoid excessive heat above 40"C (104"~ • do not use if the blue band around the capsule is missing
or broken
Inactive ingredients anhydrous citric acid, carrageenan, colloidal sil icon dioxide, FD&C Blue #1, hypromellose, medium chain triglycerides, pharmaceutical ink, potassium chloride, soy lecithin, titanium dioxide
Questions or comments Callt-800-123-4567 8:30AM · 4:00PM ET, Monday · Friday
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LOT & EXP
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'----------------- ~
RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION
Drug Facts Active ingredient Purpose (in each capsule} Aspirin (NSAID)' 325mg ... .... . Pain re liever/fever reducer ·nonsteroidal anti-inflammatory drug
Uses • lor the temporary reliel of minor aches and pains associated with:
• a cold • headache • backache • toothache • premenstrual & menstrual cramps • minor pain of arthritis
• temporarily reduces fever
Warnings Reye's syndrome: Children and teenagers who have or are recovering from ch icken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction wh ich may include: • hives • facial swelling • shock • asthma (wheezing) This product contains soy. 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
Reference ID: 3244430Reference ID: 3244833
FRONT SIDE
· orug Facts------------------ -: Active ingredient (in each capsule) Purpose : Aspirin (NSAID)' 325mg ................... Pain reliever/fever reducer I
•nonsteroidalanti ·inAammatorydrug 1
Uses •forthetemporaryreliefof minor achesandpains
assoCiated with: • a cold • headache • backache • toothache • premenstrual&menstrua l cramps •minorpainof arthritls
•temporarily reduces fever
Warnings Reye's syndrome: Ch ildren and teenagers who have or are recovering from chickenpoxor Au-likesymptomsshouldnotusethlsproduct. When using this 1 product, ifchanges~n behaviorwithnauseaandvomitingoccur,consulta doctorbecausethesesymptomscould beanearlysignofReye'ssyndrome, a 1 ra rebutseriousil lness.
Allergy alert: Aspirin may cause a severe al lerg ic reaction which may include: 1 • h1ves • facia l swelling • shock • asthma(wheezing) This product contains soy.
Stomach bleeding warning: Th1s product contains an NSAID, which may causeseverestomachbleeding. The chance is higher if you: • areage60orolder • havehadstomachulcersorbleedingproblems • 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 wh ile using this product
• take more or for a longer time than directed
Do not use if you have ever had an allergic reaction to aspirin or any otherpainrel iever/fever reducer.
Ask a doctor before use if • stomachbleedingwarningappliestoyou • you have a h1storyofstomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhos1s, or
kidney disease • you are taking a diuretic • you have asthma
Ask a doctor or pharmacist before use if you are 1•takingaprescript1ondrugfordiabetes,gout orarthritis
I
: + Continue Reading
BACKSIDE
r-------------------------: Drug Facts (continued) 1 Stop use and ask doctor if : • an allergic reat1on occurs. Seek med1cal help 1 rightaway. 1 • you experience any of the following signs of 1 stomach bleeding:
• feel faint • vom1t blood • have bloody or black stools
1 • have stomach pain that does not get better 1 • pain gets worse or lasts more than 10 days 1 • fevergetsworseorlastsformorethan3days 1 • ringing in the ears or loss of hearing occurs 1 • redness or swelling ispresentin thepainfularea : • anynewsymptomsoccur. These could besignsofaseriouscondition.
1
: If pregnant or breast-feeding, ask a health care profess ional before use. 1
1 ltisespecially importantnottouseaspirinduring thelast3monthsof 1 pregnancyunless definitelydirectedtodosobyadoctorbecauseit may 1 cause problems in the unborn ch ild or complications during delivery. 1 Keep out of reach of children. In case of overdose, 1 consult adoctorgetmedicalhelporcontacta Poison : Control Center right away.
1 Directions : • drink a ful l glass of water with each dose
1 • adu ltsandchl ldren12yearsandover: • take 1 or 2 capsulesevery4 hours or 3 capsu les every6hourswhllesymptomspersist
1 • do not exceed 12 capsules in 24 hours 1 • children under 12 years: consult a doctor
: Other information 1 • savecartonforfulld~rections a ndwarnings 1 • store at 15 - lO'C (59 - 86'F) 1 • avo1d excessive heat above 40'C (104'F) 1
• do not use if the blue band around the capsule is miss~ng or broken
: Inactive ingredients anhydrous citric acid, carrageenan, colloida l 1 sil1con dioxide, FD&C Blue #1, hypromel lose, medium chain triglycerides, : pharmaceutical ink, potass1um chloride, soy lecithin, titanium d1oxide
1 Questions or comments : Calll-800-123·4567 8:30AM - 4:00PM ET, Monday - Friday
Plx Pharma Inc. 1
8285 El Rio, Suite 130 1
Houston, TX 77054 Tel: 713-842-1249 1
Fax: 713-842-3052 1
Distributed by: Company XXX
1 Visit us at www.companyxxx.com 1
-------------------------~
NDC!: l ll4-5678-90
ASPIRIN Aspirin Capsules, 325mg Pain Reliever I Fever Reducer (NSAID)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL WITH REPEATED TEXT"SEALED FOR YOUR PROTECTION" UNDER CAP IS MISSING OR BROKEN.
~ PEEL
+
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Reference ID: 3244430Reference ID: 3244833
No Print Glue Area
Drug Facts (continued} • 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
Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or
kidney disease • you are taking a diuretic • you have asthma
Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout or arthritis
Stop use and ask doctor if • an allergic reation occurs. Seek medical help right away. • 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
• pain gets worse or lasts more than 1 0 days • fever gets worse or lasts for more than 3 days • ringing in the ears or loss of hearing occurs • redness or swelling is present in the painful area • any new symptoms occur. These could be signs of a
serious condition.
No Print Glue Area
If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin 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 • drink a full glass of water with each dose • adults and children 12 years and over:
• take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist
• do not exceed 12 capsules in 24 hours • children under 12 years: consult a doctor
Other information • save carton for full directions and warnings • store at 15 · 30'C (59 · 86' F) • avoid excessive heat above 40'C (1 04' F) • do not use if the blue band around the capsule is missing
or broken
Inactive ingredients anhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C Blue #1, hypromellose, medium chain triglycerides, pharmaceutical ink, potassium chloride, soy lecithin, titanium dioxide
Questions or comments Call1·800-123-4567 8:30 AM - 4:00 PM ET, Monday - Friday
\ non printing dieline
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Plx Pharma Inc. 8285 El Rio, Suite 130 Houston, TX 77054 Tel: 713-842-1249 Fax: 713-842-3052
Distributed by: Company XXX Visit us at www.companyxxx.com
Lot & Exp
Ill~ 6 28 4
RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION
Drug Facts Active ingredient Purpose (in each capsule} Aspirin (NSAID)' 325mg . . . . . ... Pain reliever/fever reducer 'nonsteroidal anti-inflammatory drug
Uses • for the temporary relief of minor aches and pains associated with:
• a cold • headache • backache • toothache • premenstrual & menstrual cramps • minor pain of arthritis
• temporarily reduces fever
Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing) This product contains soy.
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
Reference ID: 3244430Reference ID: 3244833
ASPIRIN Aspirin Capsules, 325mg Pain Reliever I Fever Reducer (NSAID/
Pharmaceutics International, Hunt Valley, MD 211031
--------- --4
ASPIRIN Aspirin Capsules, 325mg
(NSAID)
EXPIRES: 00/00/2013 LOT#:012345 Pharmaceutics International
Hunt Valley, MD 21D31
ASPIRIN Aspirin Capsules, 325mg
(NSAID)
EXPIRES: 00/00/2013 LOT#:012345 Pharmaceutics International
Hunt Valley, MD 21D31
ASPIRIN Aspirin Capsules, 325mg
(NSAID)
EXPIRES: 00/00/2013 LOT#:012345
Pharmaceutics International Hunt Valley, MD 21031
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Hunt Valley, MD 21D31
ASPIRIN Aspirin Capsules, 325mg
(NSAID)
EXPIRES: 00/00/2013 LOT#:012345
Pharmaceutics International Hunt Valley, MD 21031
ASPIRIN Aspirin Capsules, 32Smg
(NSAID)
EXPIRES: 00/00/2013 LOT#:012l45 Pharmaceutics International
Hunt Valley, MD 21D31
ASPIRIN Aspirin Capsules, 325mg
(NSAID)
EXPIRES: 00/00/2013 LOT#: 012345
Pharmaceutics International Hunt Valley, MD 21031
Reference ID: 3244430Reference ID: 3244833
---
TAMPER EVIDENT: DO NOT USE IF BLISTER IS OPEN OR TORN OR IF THE BAND AROUND THE CAPSULE IS MISSING OR BROKEN
Active ingredient (in each capsule) Purpose Aspirin (NSAID)* 325mg .............. . .... Pa1n reliever/fever reducer *nonsteroidalanti-infiammatorydrug
• for the temporary relief of minor aches and pains associated with: • a cold • headache • backache • toothache • premenstrual & menstrual cramps • minor pain of arthritis
• temporanly reduces fever
Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or fiu-l1kesymptomsshouldnotuseth1sproduct. Whenusingthisproduct, ifchangesm behavior w1th nausea and vom1ting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction wh1ch may include: • hives • facia l swelling • shock • asthma (wheezing) Th1s product contains soy. Stomach bleeding warning: Th1s 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 bleed1ng 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
Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if • stomach bleed1ng warning applies to you • you have a h1story of stomach problems, such as heartburn
Drug Facts (continued) • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout or arthritis
Stop use and ask doctor if • an allergic reation occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding:
• feel faint • vomit blood • have bloody or black stools • have stomach pa1n that does not get better
• pain gets worse or lasts more than 10 days • fever gets worse or lasts fo r more than 3 days • ringing in the ears or loss of hearing occurs • redness or swelling is present m the painful area • any new symptoms occur. These could be signs of a serious cond ition.
If pregnant or breast-feeding, ask a health care professional before use. It is especially Important not to use aspinn 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 Po1son Control Center right away.
Directions • drink a full glass of water with each dose • adults and children 12 years and over:
• take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist
• do not exceed 12 capsules in 24 hours • children under 12 consult a doctor
Other information • save carton for full directions and warnmgs • store at 15- 30'C (59 - 86'F) • avoid excessive heat above 40'C (104'F) • do not use if the bl ister is open or torn or if the band around the capsule is
missing or broken
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Active ingredient (in each capsule) Purpose Aspirin (NSAIO)* 32Smg ................... Pain rel iever/fever reducer *nonsteroidal anti-inflammatory drug
• for the temporary rel1ef of minor aches and pains assoCiated with: • a co ld • headache • backache • toothache • premenstrual & menstrual cramps • minor pain of arthritis
• temporarily reduces fever
Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu -like symptoms should not use this product. When using this product, if changes in behavior with nausea and vom1ting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a ra re but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing) Th is product contains soy. 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
NSA!Ds [asp~rin, ibuprofen, naproxen, or others] • have 3 or more alcohol ic drinks every day while using this product • take more or for a longer time than directed
Do not use if you have ever had an allergic react1on to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if • stomach bleeding warn~ng applies to you • you have a history of stomach problems, such as heartburn
Inactive ingredients anhydrous citric acid, ca rrageenan, col loidal silicon dioxide, FD&C Blue #1, hypromellose, medium chain triglycerides, pharmaceutical ink, potassium ch loride, soy lecithin, titanium dioxide
• you have h1gh blood pressure, heart d1sease, liver cirrhosis, or k1dney d1sease • you are taking a diuretic • you have asthma Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout or arthritis
Stop use and ask doctor if • an allergic reation occurs. Seek medical help right away. • you expe rience any of the following signs of stomach bleeding:
• feel faint • vomit blood • have bloody or black stools • have stomach pa1n that does not get better
• pain gets worse or lasts more than 10 days • fever gets worse or lasts for more than 3 days • ringing m the ears or loss of hearing occurs • redness or swellmg is present in the pa inful area • any new symptoms occur. These could be s1gns of a senous condition.
If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspinn during the last 3 months of pregnancy unless definitely directed to do so by a doctor because 1t may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get med1cal help or contact a Po1son Control Center r1ght away.
Directions • drink a full glass of water with each dose • adults and children 12 years and over:
• take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours wh1le symptoms persist
• do not exceed 12 capsules in 24 hours
• store at 15 - 30'C (59 - 86'F)
Questions or comments Call l -800·123-4567 8:30AM · 4:00PM ET, Monday · Friday
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Reference ID: 3244430Reference ID: 3244833
---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------
JOEL SCHIFFENBAUER01/14/2013
Reference ID: 3244833