Label: PHARBEDRYL- diphenhydramine hcl capsule
- NDC Code(s): 16103-348-03, 16103-348-08, 16103-348-11
- Packager: Pharbest Pharmaceuticals, Inc.
- 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 June 13, 2023
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- Active ingredient (in each capsule)
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INGREDIENTS AND APPEARANCE
PHARBEDRYL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-348 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 (PINK (clear) , WHITE (clear) , RED (band) ) 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:16103-348-03 1 in 1 CARTON 02/01/2016 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:16103-348-08 1 in 1 CARTON 02/01/2016 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:16103-348-11 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/01/2016 Labeler - Pharbest Pharmaceuticals, Inc. (557054835) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 analysis(16103-348) , manufacture(16103-348) , pack(16103-348) , label(16103-348)