Label: DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 58599-003-25, 58599-003-29, 58599-003-35, 58599-003-90 - Packager: PURINEPHARMA LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated August 14, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- HOW SUPPLIED
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58599-003 Route of Administration ORAL, Type 0: Not a Combination Product 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 D&C RED NO. 28 (UNII: 767IP0Y5NH) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color PINK (PINK CAP and WHITE BODY) Score 2 pieces Shape CAPSULE Size 14mm Flavor Imprint Code DH;25 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58599-003-90 50000 in 1 BOX 2 NDC:58599-003-25 1 in 1 CARTON 2 50 in 1 BOTTLE 3 NDC:58599-003-29 1 in 1 CARTON 3 100 in 1 BOTTLE 4 NDC:58599-003-35 1 in 1 CARTON 4 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/31/2014 Labeler - PURINEPHARMA LLC (019950491) Registrant - PURINEPHARMA LLC (019950491) Establishment Name Address ID/FEI Business Operations PURINEPHARMA LLC 019950491 manufacture(58599-003)