Label: DIPHENHYDRAMINE capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 15, 2011

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  • Active ingredient

    Diphenhydramine HCl 25mg

    Diphenhydramine HCl 50mg

  • Purpose

    Antihistamine

  • Keep Out of Reach of Children

  • Uses

    Temporarily relieves: ° hay fever or other upper respiratory allergies like: ° runny nose

    ° sneezing ° watery eyes ° itchy nose or throat

  • Warnings

    Do not use with any other product containing Diphenhydramine HCl, including one applied topically.

    Ask a doctor or pharmacist before use if you have ° trouble urinating due to enlarged prostate gland ° a breathing problem such as emphysema or chronic bronchitis ° glaucoma ° if you are taking sedatives or tranquilizers

    When using this product ° avoid alcoholic drinks ° marked drowsiness may occur ° excitability may occur, especially in children ° alcohol, sedatives & tranquilizers may increase drowsiness ° be careful when driving a motor vehicle or operating machinery.

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

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

  • Directions

    ° take every 4-6 hours

    ° do not take more than 6 doses in 24 hours.

    Adults & children 12 years & over: 1-2 capsules

    Children 6 to under 12 years: 1 capsule

    Children under 6: ask a doctor

  • Other Information

    Store at room temperature 15°-30°C (59°-86°F)

    Protect from excessive moisture

  • Inactive ingredients

    Lactose Monohydrate, Silicon Dioxide, Magnesium Steareate, Black Iron Oxide, Gelatin, Sodium Lauyl Sulfate, D&C Red No. 28, FD&C Red No. 40, FD&C Blue No. 1.

    Distributed by:

    SDA Laboratories, Inc.

    Greenwich, CT 06830

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • Package/Label Principal Display Panel

    Diphenhydramine HCl 25mg

  • Package/Label Principal Display Panel

    Diphenhydramine HCl 50mg

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE 
    diphenhydramine capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-304(NDC:66424-020)
    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 MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorPINK (Pink/White) Scoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code PH;014
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-304-1515 in 1 BOTTLE
    2NDC:21695-304-2020 in 1 BOTTLE
    3NDC:21695-304-2424 in 1 BOTTLE
    4NDC:21695-304-3030 in 1 BOTTLE
    5NDC:21695-304-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2007
    DIPHENHYDRAMINE 
    diphenhydramine capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-500(NDC:66424-021)
    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 MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code PH;013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-500-1515 in 1 BOTTLE
    2NDC:21695-500-2020 in 1 BOTTLE
    3NDC:21695-500-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2007
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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