Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled
- NDC Code(s): 35916-0438-1
- Packager: Softgel Healthcare Pvt Ltd
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 25, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- PURPOSE
- Uses
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Inactive ingredients
- Bottle Label
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35916-0438 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBITOL (UNII: 506T60A25R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color blue ((Transparent)) Score score with uneven pieces Shape CAPSULE ((Oval)) Size 13mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35916-0438-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 01/10/2024 Labeler - Softgel Healthcare Pvt Ltd (675584180) Establishment Name Address ID/FEI Business Operations SOFTGEL HEALTHCARE PRIVATE LIMITED 675584180 manufacture(35916-0438)