ASPIRIN ' xQ J - Food and Drug Administration · No Print Glue Area Drug Facts (continued} • have...

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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'----------------- ~

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


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


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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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


• 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:


• 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

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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


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


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


(NSAID)

EXPIRES: 00/00/2013 LOT#:012345 Pharmaceutics International



(NSAID)

EXPIRES: 00/00/2013 LOT#:012345

Pharmaceutics International Hunt Valley, MD 21031

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ASPIRIN Aspirin Capsules, 32Smg

(NSAID)

EXPIRES: 00/00/2013 LOT#:012l45 Pharmaceutics International



(NSAID)

EXPIRES: 00/00/2013 LOT#: 012345



---

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


• 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.



• 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


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.


• 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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---------------------------------------------------------------------------------------------------------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

ASPIRIN ' xQ J - Food and Drug Administration · No Print Glue Area Drug Facts (continued} • have...

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Transcript of ASPIRIN ' xQ J - Food and Drug Administration · No Print Glue Area Drug Facts (continued} • have...