Label: DIMENHYDRINATE - dimenhydrinate tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • ACTIVE INGREDIENT

    EACH TABLET CONTAINS DIMENHYDRINATE 50 MG

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  • INACTIVE INGREDIENT


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

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  • PURPOSE

    Antiemetic

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  • 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

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  • 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

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  • WARNINGS

    Warnings

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

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  • INDICATIONS & USAGE

     

    Use

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

    nauseavomitingdizziness

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  • 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.

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  • ASK DOCTOR/PHARMACIST

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

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  • 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.

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  • PREGNANCY OR BREAST FEEDING

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

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  • INGREDIENTS AND APPEARANCE
    DIMENHYDRINATE  
    dimenhydrinate tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49483-352
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMENHYDRINATE (DIPHENHYDRAMINE) DIMENHYDRINATE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    ANHYDROUS LACTOSE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 8mm
    Flavor Imprint Code TCL;352
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-352-36 36 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 01/28/2011
    Labeler - Time Cap Labs, Inc (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    Time Cap Labs, Inc. 037052099 manufacture(49483-352)
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