Label: ASPIRIN 81MG- aspirin tablet, delayed release
- NDC Code(s): 21130-428-12, 21130-428-20
- Packager: BETTER LIVING BRANDS LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 5, 2025
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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:•hives • facial swelling • asthma (wheezing) • 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 problem
- 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 DOCTOR
- ASK DOCTOR/PHARMACIST
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STOP USE
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
- ringing in the ears or a loss of hearing occurs
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
- PREGNANCY
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, triethyl citrate
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INGREDIENTS AND APPEARANCE
ASPIRIN 81MG
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-428 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 STARCH, CORN (UNII: O8232NY3SJ) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T) SODIUM HYDROXIDE (UNII: 55X04QC32I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TALC (UNII: 7SEV7J4R1U) FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color pink (Peach Colored tablets) Score no score Shape ROUND Size 7mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-428-12 1 in 1 CARTON 08/08/2023 1 120 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:21130-428-20 1 in 1 CARTON 08/08/2023 2 200 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 08/08/2023 Labeler - BETTER LIVING BRANDS LLC. (009137209) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(21130-428)




