Label: ACETAMINOPHEN ASPIRIN AND CAFFEINE tablet
- NDC Code(s): 14803-135-00
- Packager: Elysium Pharmaceutical Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 1, 2025
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN ASPIRIN AND CAFFEINE
acetaminophen aspirin and caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14803-135 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) N-VINYLPYRROLIDINONE (UNII: 76H9G81541) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white Score no score Shape CAPSULE Size 18mm Flavor Imprint Code S53 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14803-135-00 30000 in 1 BOTTLE; Type 0: Not a Combination Product 01/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/30/2024 Labeler - Elysium Pharmaceutical Ltd (915664486) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceutical Ltd 915664486 manufacture(14803-135) , analysis(14803-135)
