Label: DIPHENDYDRAMINE HYDROCHLORIDE capsule

  • Category: HUMAN OTC DRUG LABEL

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 July 30, 2010

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  • DRUG FACTS

  • ACTIVE INGREDIENT (IN EACH CAPSULE)

    Diphenhydramine Hydrochloride 25 mg & 50 mg

  • PURPOSE

    Antihistamine

  • USES

    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

    Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

    Ask a doctor before use if you have

    glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

    Ask a doctor or pharmacist before use if you are

    taking taking tranquilizers or sedative.

    When using this product

    you may get drowsy; 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. Do not use any other products containing diphenhydramine.

    If pregnant or breast-feeding,

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

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222

  • 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 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.

    Children under 6 years of age: ask a doctor

  • OTHER INFORMATION

    Store at controlled room temperature 59-86 degrees F.

  • INACTIVE INGREDIENTS

    Lactose, starch, gelatin with bisulfites and artificial colors.

  • QUESTIONS OR COMMENTS?

    Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

    call toll free 734-743-6000

    Repackaged by:

    Contract Pharmacy Services-PA
    125 Titus Ave Suite 200
    Warrington, PA 18976 USA

    Original--08/2010--NJW

  • Package Label

    25 mg Capsules

    25 mg Capsules

  • Package Label

    50 mg Capsules

    50 mg Capsules

  • INGREDIENTS AND APPEARANCE
    DIPHENDYDRAMINE HYDROCHLORIDE 
    diphendydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-125(NDC:0904-5306)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-125-3030 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34508/05/2010
    DIPHENDYDRAMINE HYDROCHLORIDE 
    diphendydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-126(NDC:0904-5307)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-126-3030 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34508/05/2010
    Labeler - Contract Pharmacy Services-PA (945429777)
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