Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • Active ingredient

    Diphenhydramine Hydrochloride 25 mg

  • Purpose

    Antihistamine

  • Use

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

  • Warnings:  Do not use

    • to make a child sleepy

    • with any other product containing diphenhydramine, even one used on skin

  • 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

  • When using this product

    • marked drowsiness may occur

    • avoid alcoholic drinks

    • alcohol, sedatives, and tranquilizers may increase drowsiness

    • be careful when driving a motor vehicle or operating machinery

    • excitability may occur, especially in children

  • Pregnancy/breast-feeding warning

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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

    Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature].  Protect from excessive moisture.

  • Inactive ingredients

    D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

  • Questions?

    Questions or comments? (800) 616-2471

    Distributed by

    MAJOR® PHARMACEUTICALS

    31778 Enterprise Drive

    Livonia, MI  48150 USA

    Repackaged by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    Re-Order No. 301574

  • PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HCL CAPSULES 25MG

    63187-771-20
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-771(NDC:0904-5306)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINKScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-771-2020 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
    2NDC:63187-771-3030 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2016
    3NDC:63187-771-6060 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2016
    4NDC:63187-771-9090 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/02/2009
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-771)
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