Label: DIPHENHYDRAMINE HCL capsule
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NDC Code(s):
55289-479-10,
55289-479-12,
55289-479-15,
55289-479-20, view more55289-479-24, 55289-479-30
- Packager: PD-Rx Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 16103-348
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 12, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Uses
- Warnings
- Ask a doctor before use if you have
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
- 12.5 mg dosage strength is not available in this bottle.
- Do not attempt to break capsule.
adults and children 12 years of age and over 25 mg to 50 mg (1-2 capsules) children 6 to under 12 years of age 12.5 mg**to 25 mg (1 capsule) children under 6 years of age Ask a doctor - Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55289-479(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:55289-479-10 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2021 2 NDC:55289-479-12 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2021 3 NDC:55289-479-15 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2021 4 NDC:55289-479-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2021 5 NDC:55289-479-24 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2021 6 NDC:55289-479-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/01/2016 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(55289-479)