Label: GENUINE ASPIRIN- aspirin tablet, film coated
- NDC Code(s): 59779-389-12
- 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 July 27, 2016
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- Active ingredient (in each caplet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
Pain reliever/fever reducerClose
- temporarily relieves:
- pain and fever of colds
- muscle pain
- menstrual pain
- minor pain of arthritis
- temporarily relieves:
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:
- facial swelling
- 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 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
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
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
- 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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
These could be signs of 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, 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 and children 12 years and over: take 1 to 2 caplets every 4 hours. Do not take more than 12 caplets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, hypromellose, polyethylene glycol, propylene glycolClose
- Questions or comments?
- Principal display panel
Compare to the active ingredient in Genuine Bayer® Regular Strength†
Aspirin 325 mg
Pain reliever, Fever reducer (NSAID)
Fast, safe pain relief
• Everyday aches & pains
100 COATED CAPLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Genuine Bayer® Regular Strength.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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- INGREDIENTS AND APPEARANCE
aspirin tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-389 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE Score no score Shape OVAL Size 14mm Flavor Imprint Code 44;389 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-389-12 1 in 1 CARTON 05/17/2001 07/08/2019 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/17/2001 07/08/2019 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(59779-389) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(59779-389)