Label: UNCOATED ASPIRIN- aspirin tablet
- NDC Code(s): 59779-249-16, 59779-249-32
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated September 26, 2016
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- Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*Close
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducerClose
provides temporary relief of
- pain and fever of colds
- muscle pain
- minor pain of arthritis
- menstrual pain
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:
- asthma (wheezing)
- facial swelling
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 more or for a longer time than directed
- 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
Ask a doctor before use if
- you have liver cirrhosis
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have asthma
- you have heart or kidney disease
- you have taken a diuretic
- you have high blood pressure
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
- redness or swelling is present
- any new symptoms occur
- fever gets worse or lasts more than 3 days
- 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 (1-800-222-1222) 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
Fever reducer (NSAID)
• Caffeine free
• Sodium free
120 TABLETS, 325 mg
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2011 CVS/pharmacy
TAMPER EVIDENT: DO NOT USE IF PRINTED
SEAL UNDER CAP IS BROKEN OR MISSING
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-249 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code ASPIRIN;44;249 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-249-32 1 in 1 CARTON 08/04/1993 1 120 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59779-249-16 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/04/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 08/04/1993 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(59779-249) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(59779-249)