Label: DIPHENHYDRAMINE HCL capsule

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

Drug Label Information

Updated March 5, 2024

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  • Active Ingredient (in each banded capsule)

    Diphenhydramine HCl… 50 mg

  • Purpose

    Antihistamine

  • Use

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

    Do not use

    •
    to make a child sleepy
    •
    with any other product containing diphenhydramine, including one applied topically
  • Ask a doctor before use if you have

    •
    glaucoma
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    difficulty in urination due to enlargement of the prostate gland
  • Ask a doctor or pharmacist

    before use if you are taking sedatives or tranquilizers

  • 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
  • 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.

  • Directions

    •
    Take every 4-6 hours
    •
    Do not take more than 6 doses in 24 hours

    adults and children 12 years of age and over

    1 capsule

    children 6 years to under 12 years of age

    Ask a doctor, the proper dosage strength is not available in this package**

    **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

  • Other Information

    •
    Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
    •
    Protect from moisture
    •
    Contains lactose
  • 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
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L32991870224

  • Principal Display Panel

    Diphenhydramine HCl Capsules

    50 mg

    10 Capsules

    Bag Label
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0661(NDC:0904-2056)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (red center band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;836
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-0661-010 in 1 BAG01/02/2009
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/02/2009
    Labeler - Cardinal Health 107, LLC (118546603)
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