Label: ASPIRIN tablet, film coated
- NDC Code(s): 68016-747-10, 68016-747-30, 68016-747-50
- Packager: Chain Drug Consortium
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 14, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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:
- facial swelling
- shock
- hives
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- 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
- have had stomach ulcers or bleeding problems
- take more or for a longer time than directed
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- you are taking a diuretic
- 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
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- 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
- ringing in the ears or a 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
- new symptoms occur
These could be signs of a serious condition.
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Directions
- do not take more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
†COMPARE TO THE ACTIVE INGREDIENT
IN GENUINE BAYER® ASPIRINPremier
Value®Film-Coated
Aspirin
PAIN RELIEVER/FEVER REDUCER
(NSAID)Aid for relief of
headache,
cold discomforts,
muscular aches100 Tablets
325 mg EACHINDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEEDTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSINGDistributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087If for any reason you are not satisfied with this product, please
return it to the store where purchased for a full refund.†This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Genuine
Bayer® Aspirin. 50844 REV0122C15712
Premier Value 44-157
-
INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-747 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;157;ASPIRIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-747-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996 2 NDC:68016-747-50 300 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996 02/20/2023 3 NDC:68016-747-30 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996 10/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/10/1996 Labeler - Chain Drug Consortium (101668460) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(68016-747) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(68016-747) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(68016-747) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(68016-747) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(68016-747)