Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
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NDC Code(s):
72789-317-10,
72789-317-12,
72789-317-15,
72789-317-20, view more72789-317-30
- Packager: PD-Rx Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-7237
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 2, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Uses
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WARNINGS
Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis glaucoma
trouble urinating due to an enlarged prostate gland - Directions
- Other information
- INACTIVE INGREDIENT
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72789-317(NDC:0904-7237) 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 D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color pink (Half pink and half clear with white powder inside and sealed with red band) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CPC;835 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72789-317-10 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/05/2023 2 NDC:72789-317-12 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/05/2023 3 NDC:72789-317-15 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/05/2023 4 NDC:72789-317-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/05/2023 5 NDC:72789-317-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/14/2022 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(72789-317)