Label: DIMENHYDRINATE- dimenhydrinate tablet 

  • Label RSS
  • NDC Code(s): 0603-3327-21, 0603-3327-32
  • Packager: Qualitest Pharmaceuticals
  • 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 12/12

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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  • INDICATIONS & USAGE

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

    • nausea
    • vomiting
    • dizziness
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  • Warnings
  • DO NOT USE

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

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  • Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to 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 this product

    • marked drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • 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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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

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  • Directions

    • to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
    • to prevent or treat motion sickness, use the following dosing

    adults and children
    12 years and over 

    1-2 tablets every 4-6 hours; not more than
    8 tablets in 24 hours, or as directed by a doctor 

    children 6 years to
    under 12 years 

    1/2-1 tablet every 6-8 hours; not more than
    3 tablets in 24 hours, or as directed by a doctor 

    children 2 years to
    under 6 years 

    1/4-1/2 tablet every 6-8 hours; not more than
    1 1/2 tablets in 24 hours, or as directed by a doctor 

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  • Other information

    store at 15° to 30°C (59° to 86°F)

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

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  • Inactive ingredients

    colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid

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  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 8/09 R4
    8080234 0111

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  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for Dimenhydrinate Tablets, USP 50 mg 1000 count.

     

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  • INGREDIENTS AND APPEARANCE
    DIMENHYDRINATE 
    dimenhydrinate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0603-3327
    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  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 9mm
    Flavor Imprint Code 0111;V
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-3327-21 100 in 1 BOTTLE, PLASTIC
    2 NDC:0603-3327-32 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 03/01/2004
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE(0603-3327)
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