Label: DIPHENHYDRAMINE HCL capsule
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NDC Code(s):
43063-720-10,
43063-720-15,
43063-720-20,
43063-720-30, view more43063-720-40
- Packager: PD-Rx Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5307
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 2, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each banded capsule)
- Purpose
- Use
- WARNINGS
- Ask a doctor before use if you have
- Ask a doctor or pharmacist
- When using this product
- If pregnant or breast-feeding
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- Take every 4-6 hours
- Do not take more than 6 doses in 24 hours
adults and children 12 years of age and over Take 1 capsule (50 mg) children under 12 years of age ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package. - Other Information
- Inactive Ingredients
- Questions?
- 16 HOW SUPPLIED
- PACKAGE LABEL.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:43063-720(NDC:0904-5307) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength 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) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color pink Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CPC;836 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43063-720-10 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2023 2 NDC:43063-720-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/05/2021 3 NDC:43063-720-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/05/2021 4 NDC:43063-720-40 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/05/2021 5 NDC:43063-720-15 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/02/2009 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(43063-720)