CHEWABLE ASPIRIN- aspirin tablet, chewable 
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.

----------

CVS 44-218 Delisted

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains or as recommended by your doctor

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)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • have had stomach ulcers or bleeding problems

  • take a blood thinning (anticoagulant) or steroid drug

  • are age 60 or older

  • take more or for a longer time than directed

  • 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

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer

  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

  • stomach bleeding warning applies to you

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

  • you have asthma

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

  • you are taking a diuretic

Ask a doctor or pharmacist before use if

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:

  • vomit blood

  • have bloody or black stools

  • feel faint

  • have stomach pain that does not get better

  • an allergic reaction occurs. Seek medical help right away.

  • 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 problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, 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 not to exceed 48 tablets in 24 hours unless directed by a doctor

  • children under 12 years: do not use unless directed by a doctor

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

dextrates, ethylcellulose, FD&C yellow #6 aluminum lake, orange flavor, sodium saccharin, starch

Questions or comments?

1-800-426-9391

Principal Display Panel

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

CVS®

pharmacy

NDC 59779-218-07

Compare to the active ingredient in

Bayer® Chewable Low Dose Aspirin

See new warnings information

Chewable

ASPIRIN

ADULT LOW DOSE Aspirin Regimen**

Pain reliever (NSAID)

81 mg

36 CHEWABLE TABLETS

Chewable Orange

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

50844         ORG031021807

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com         1-800-shop-CVS

Product Label

Product Label

CHEWABLE ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-218
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DEXTRATES (UNII: G263MI44RU)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code 44;218
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-218-071 in 1 CARTON
136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/12/199003/04/2018
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 10/2015
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED