Label: ASPIRIN 81MG ADULT LOW DOSE- aspirin tablet, delayed release
- NDC Code(s): 84289-356-12
- Packager: PHARMAMED USA INC
- This is a repackaged label.
- Source NDC Code(s): 16103-356
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 26, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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 alergic reaction which may include:
- hives
- asthma (wheezing)
- facial sweling
- shock
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
- 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)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- Do not use
- Ask a doctor before use if
- 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 •vomit blood •have bloody or black stools •have stomach pain that does not get better
- allergic reaction occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions? Adverse drug event call:
- Package Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
ASPIRIN 81MG ADULT LOW DOSE
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84289-356(NDC:16103-356) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength SODIUM LAURYL SULFATE (UNII: 368GB5141J) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STEARIC ACID (UNII: 4ELV7Z65AP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code PH023 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84289-356-12 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 10/01/2024 Labeler - PHARMAMED USA INC (065607328) Registrant - PHARBEST PHARMACEUTICALS, INC. (557054835) Establishment Name Address ID/FEI Business Operations PHARBEST PHARMACEUTICALS, INC. 557054835 repack(84289-356)