Label: MOTION SICKNESS- dimenhydrinate tablet

  • 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 04/14

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

  • Active ingredient (in each tablet)

    Dimenhydrinate 50 mg

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  • Purpose

    Antiemetic

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  • Uses

    for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

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  • Warnings

    Do not use

    for children under 2 years of age unless directed by a doctor.

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to an 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
    • use caution when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    ask a health care professional before use.

    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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  • Directions

    • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
    a dults and children 12 years and over  1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor
     children 6 to under 12 years   1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor
     children 2 to under 6 years   1/4 to 1/2 tablet every 6-8 hours; not to exceed 1-1/2 tablets in 24 hours, or as directed by a doctor
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  • Other information

    • each tablet contains: calcium 30 mg
    • store at room temperature 20º-25ºC (68º-77ºF)
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  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

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  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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  • PRINCIPAL DISPLAY PANEL

    Motion Sickness

    Dimenhydrinate 50 mg/Antiemetic

    Fast Acting Motion Sickness Relief

    For Children and Adults

    Tablets 50 mg Each

    Compare to the active ingredient in Dramamine®*

    *This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Original Formula. 

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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  • Product Label

    Dimenhydrinate 50 mg

    Fred's Motion Sickness Tablets

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  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS 
    dimenhydrinate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-630
    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
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 9mm
    Flavor Imprint Code 1006;1006
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-630-12 1 in 1 CARTON
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 07/08/2010
    Labeler - Freds Inc (005866116)
    Registrant - P and L Development of New York Corporation (800014821)
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