Label: ASPIRIN 81MG- aspirin enteric coated tablets 81mg tablet, delayed release
- NDC Code(s): 60577-808-01
- Packager: VITANE PHARMACEUTICALS, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 15, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- 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
-
SPL UNCLASSIFIED SECTION
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 non-prescription NSAIDs(aspirin, ibuprofen, naproxen, 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 SECTION
- ASK A DOCTOR/PHARMACIST
-
STOP USE SECTION
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
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs.
- PREGNANCY OR BREAST FEEDING SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
- DIRECTIONS
- STORAGE
- INACTIVE INGREDIENTS
- ASK A DOCTOR BEFORE USE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASPIRIN 81MG
aspirin enteric coated tablets 81mg tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60577-808 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color yellow Score no score Shape ROUND Size 4mm Flavor Imprint Code I1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60577-808-01 1 in 1 CARTON 10/15/2025 1 60 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 10/15/2025 Labeler - VITANE PHARMACEUTICALS, INC (029029638) Establishment Name Address ID/FEI Business Operations InvaHealth Inc 116840615 manufacture(60577-808)


