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Name:Adult Low Strength Aspirin
Manufacturer:Woonsocket Prescription Center,incorporated
Category:Over-the-counter (OTC) Marketed Drugs


CVS 44-414

ADULT LOW STRENGTH ASPIRIN - aspirin tablet, coated 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS 44-414

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Use(s)

  • temporarily relieves minor aches and pains

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
  • shock
  • facial swelling
  • asthma (wheezing)

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

Do not use

  • if you have ever had an allergic reaction to any pain reliever or 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 have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • and allergic reaction occurs
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health 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 prblems 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 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use unless directed by a doctor

Other information

  • store at controlled room temperature 15º-30ºF (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

cellulose, colloidal silicon dioxidem croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, shellac wax, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-877-932-7948

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

SEE NEW WARNINGS INFORMATION

Compare to the actibe ingredient in St. Joseph®

Adult Low Strength Aspirin†

Adult Low Strength

ASPIRIN

PAIN RELIEVER (NSAID)

Safety coated to protect against stomach upset

120 Adult enteric coated tablets 81 mg each

20% MORE FREE

400 for the price of 300

Safety Coated

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844     ORG011041405

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2011 CVS/pharmacy

www.cvs.com

1-800-shop-CVS

Product Packaging

Product Packaging


ADULT LOW STRENGTH ASPIRIN 
aspirin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-414
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
HYPROMELLOSES  
POLYDEXTROSE  
POLYETHYLENE GLYCOL  
Polyvinyl Acetate Phthalate  
DIMETHICONE  
SODIUM ALGINATE  
SODIUM BICARBONATE  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
TRIETHYL CITRATE  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 44;414
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-414-32 1 BOTTLE, GLASS (1 BOTTLE) in 1 BOTTLE, PLASTIC contains a BOTTLE, GLASS
1 120 TABLET, COATED (120 TABLET) in 1 BOTTLE, GLASS This package is contained within the BOTTLE, PLASTIC (59779-414-32)
2 NDC:59779-414-07 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
2 36 TABLET, COATED (36 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59779-414-07)
3 NDC:59779-414-05 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
3 400 TABLET, COATED (400 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59779-414-05)
4 NDC:59779-414-12 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
4 100 TABLET, COATED (100 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59779-414-12)
5 NDC:59779-414-17 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
5 300 TABLET, COATED (300 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59779-414-17)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 01/14/2004

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 05/2011 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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