Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
- NDC Code(s): 63187-771-20, 63187-771-30, 63187-771-60, 63187-771-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-5306
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 1, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings: Do not use
- Ask a doctor before use if you have
- When using this product
- Pregnancy/breast-feeding warning
- Keep out of reach of children
-
Directions
Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours, not more than 12 capsules in 24 hours.
Children 6 years to 12 years of age: take 12.5 mg** (1 capsule) every 4 to 6 hours, not more than 6 capsules in 24 hours.
Children under 6 years of age: do not use
**12.5mg dosage strength is not available in this package. Do not attempt to break capsule
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HCL CAPSULES 25MG
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-771(NDC:0904-5306) 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 LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) STARCH, CORN (UNII: O8232NY3SJ) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) D&C RED NO. 28 (UNII: 767IP0Y5NH) Product Characteristics Color PINK 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:63187-771-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017 2 NDC:63187-771-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2016 3 NDC:63187-771-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2016 4 NDC:63187-771-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/02/2009 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-771)