Label: DIPHENHYDRAMINE HCL capsule
- NDC Code(s): 45865-583-20, 45865-583-30
- Packager: medsource pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 66424-020
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 19, 2018
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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
- Package Label - Bottle of 20
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45865-583(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 (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:45865-583-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018 2 NDC:45865-583-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/27/2010 Labeler - medsource pharmaceuticals (833685915) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations medsource pharmaceuticals 833685915 repack(45865-583)