Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet, coated
- NDC Code(s): 49483-329-00
- Packager: Time-Cap Labs, Inc
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated December 17, 2018
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- ACTIVE INGREDIENT
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- WHEN USING
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-329 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE Size 7mm Flavor Imprint Code help Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-329-00 100000 in 1 CARTON; Type 0: Not a Combination Product 12/17/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2010 Labeler - Time-Cap Labs, Inc (037052099) Registrant - Time-Cap Labs, Inc (037052099) Establishment Name Address ID/FEI Business Operations Time-Cap Labs, Inc 037052099 manufacture(49483-329)