Your browser does not support JavaScript! UNCOATED ASPIRIN (ASPIRIN) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]
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RxNorm Names

UNCOATED ASPIRIN (aspirin) tablet
[WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

provides temporary relief of

  • headache
  • pain and fever of colds
  • muscle pain
  • menstrual pain
  • toothache
  • minor pain of arthritis

Warnings

Reye's syndrome: Children and teenagers who have or 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
  • asthma (wheezing)
  • shock

Stomach bleeding warning: This product 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)
  • take more or for a longer time than directed
  • 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

Ask a doctor before use if

the stomach bleeding warning applies to you

  • you have a history of stomach problems, such as heartburn
  • you have liver cirrhosis
  • you have asthma
  • you have high blood pressure
  • you have heart or kidney disease
  • you have taken a diuretic

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking a prescription drug for diabetes, gout or arthritis

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
  • an allergic reaction occurs.  Seek medical help right away.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

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, get medical help or contact a Poison Control Center right away.

Directions

  • drink a full glass of water with each dose
  • adults: 1 to 2 tablets with water.  Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours.
  • children under 12: consult a doctor

Other information

  • store at room temperature
  • use by expiration date on package

Inactive ingredients

starch

Questions or comments?

1-800-426-9391

Principal Display Panel

The packaging shown below represents a sample of what's currently in use.  Additional packaging may be available.

value size

1000 tablets

NDC-59779-249-16

CVS®

pharmacy

See new warnings information

Uncoated

ASPIRIN

TABLETS

PAIN RELIEVER/FEVER REDUCER (NSAID)

Caffeine free

Sodium free

1000 TABLETS, 325 mg

50844   REV0510D24916

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com   1-800-shop-CVS

#233019

1000 label
UNCOATED ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-249
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;249
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-249-161000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/04/1993
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 5/2011
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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