Label: DIPHENHYDRAMINE HCL capsule
- NDC Code(s): 50090-5716-0, 50090-5716-3
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 66424-020
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 4, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Uses:
- Warnings:
- Do not use
- Ask a doctor or pharmacist before use
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children
- Directions:
- Other information:
- Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate
- HOW SUPPLIED
- DIPHENHYDRAMINE HCL
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-5716(NDC:66424-020) 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color pink Score no score Shape CAPSULE Size 14mm Flavor Imprint Code PH014 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-5716-0 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2021 2 NDC:50090-5716-3 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/27/2010 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-5716) , REPACK(50090-5716)