Label: DIPHENDYDRAMINE HYDROCHLORIDE capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 7, 2013

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • ACTIVE INGREDIENT (IN EACH CAPSULE)

    Diphenhydramine Hydrochloride 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

    Do not use

    • with any other products 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 taking tranquilizers or sedative.

    When using this product

    • marked drowsiness may occur

    • avoid alcoholic drinks

    • alcohol, sedatives and tranquilizers may increase drowsiness

    • use caution 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

    Adults and children 12 years and over: take 1 capsule (50mg) every 4 to 6 hours; not more than 6 capsules in 24 hours.

    Children under 12 years: 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 25mg package.

  • OTHER INFORMATION

    • store at controlled room temperature. USP

    • do not use if either capsule band or imprinted safety seal under cap is broken or missing

    • protect from excessive moisture

    • use by expiration date on package

    • contains lactose

  • INACTIVE INGREDIENTS

    D&C red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose and starch.

  • QUESTIONS?

    Adverse drug event call: (800) 616-2471

    Distributed by:

    Major® Pharmaceuticals

    31778 Enterprise Drive

    Livonia, MI 48150 USA M-29

    R 12/09

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel-Diphenhydramine HCI Capsules 50mg

  • INGREDIENTS AND APPEARANCE
    DIPHENDYDRAMINE HYDROCHLORIDE 
    diphendydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7657(NDC:0904-5307)
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    GELATIN (UNII: 2G86QN327L)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize4mm
    FlavorImprint Code cpc;836
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0615-7657-3930 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33601/02/2009
    Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
    Establishment
    NameAddressID/FEIBusiness Operations
    NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-7657) , REPACK(0615-7657)