Label: DIMENHYDRINATE tablet, film coated

  • 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 March 27, 2013

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  • ACTIVE INGREDIENT

    EACH TABLET CONTAINS DIMENHYDRINATE 50 MG

  • INACTIVE INGREDIENT


    COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM,HYPROMELLOSE, AHNYDROUS LACTOSE, MAGNESIUM STEARATE, CELLULOSE, MICROCRYSTALLINE, MINEROL

  • PURPOSE

    Antiemetic

  • 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

  • DOSAGE & ADMINISTRATION

    irections:

    To prevent motion sickness, the first dose should be taken one-half to one hour before starting activity.

    Adults and children 12 years of age and over - 1 to 2 tablets every 4 to 6 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor

    Children 6 to under 12 years of age 1/2 to 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor

    Children 2 to under 6 years of age - 1/4 to 1/2 tablet every 6 to 8 hours,not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

  • WARNINGS

    Warnings

    Do not use for children under 2 years of age unless directed by a doctor

  • INDICATIONS & USAGE

     

    Use

    for prevention and treatment of these symptoms associated with motion sickness:

    nauseavomitingdizziness

  • ASK DOCTOR

    Ask a doctor before use if you have glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty in urination due to an enlargement of the prostate gland.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

  • WHEN USING

    When using this product: do not exceed recommended dosage; marked drowsiness may occur; avoid alcoholic drinks; alcohol, sedatives, and tranquilizers may increase drowsiness.  Be careful when driving a motor vehicle or operating machinery.

  • PREGNANCY OR BREAST FEEDING

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

  • PRINCIPAL DISPLAY PANEL

    blister

  • INGREDIENTS AND APPEARANCE
    DIMENHYDRINATE  
    dimenhydrinate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-352
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code TCL;352
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-352-3636 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33601/28/2011
    Labeler - Time Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Labs, Inc.037052099manufacture(49483-352)