Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled
- NDC Code(s): 82501-1578-2
- Packager: Gobrands, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 8, 2023
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- Official Label (Printer Friendly)
- Active Ingredient (in each softgel)
- Purpose
- Uses
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WARNINGS
Do not use ● for children under 12 years of age ● with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have ● a breathing problem such as asthma, emphysema, or chronic bronchitis ● glaucoma ● difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use ifyou are taking sedatives, tranquilizers or any other sleep aid
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82501-1578 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color purple Score no score Shape OVAL Size 15mm Flavor Imprint Code 602 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82501-1578-2 1 in 1 CARTON 05/16/2022 1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 05/16/2022 Labeler - Gobrands, Inc (057499049) Registrant - Spirit Pharmaceuticals LLC (179621011)