Label: UNCOATED ASPIRIN- aspirin tablet
- NDC Code(s): 59779-249-16
- Packager: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
Pain reliever/fever reducer
provides temporary relief of
- pain and fever of colds
- muscle pain
- menstrual pain
- minor pain of arthritis
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:
- facial swelling
- asthma (wheezing)
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
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.
- 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
- Questions or comments?
- Principal Display Panel
The packaging shown below represents a sample of what's currently in use. Additional packaging may be available.
See new warnings information
PAIN RELIEVER/FEVER REDUCER (NSAID)
1000 TABLETS, 325 mg
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2010 CVS/pharmacy
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-249 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (ASPIRIN) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;249 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-249-16 1000 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 08/04/1993 Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)