DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated
Diphenhydramine hydrochloride by
Drug Labeling and Warnings
Diphenhydramine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Elysium Pharmaceuticals Ltd, Elysium Pharmaceuticals Ltd.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 14803-273 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) D&C RED NO. 17 (UNII: ND733RX3JN) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYVINYL ALCOHOL (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Product Characteristics Color pink Score no score Shape CAPSULE Size 11mm Flavor Imprint Code S4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 14803-273-00 100000 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/07/2024 Labeler - Elysium Pharmaceuticals Ltd (915664486) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceuticals Ltd. 915664486 manufacture(14803-273) , analysis(14803-273)
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