Label: DRAMAMINE- dimenhydrinate tablet, chewable 

  • Label RSS
  • 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.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Dimenhydrinate 50 mg

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  • Purpose

    Antiemetic

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  • Use

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

    • nausea
    • vomiting
    • dizziness
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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
    • trouble urinating due to an enlarged 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
    • be careful when driving a motor vehicle or operating machinery

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

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

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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, see below:
    adults and children 12 years and over
    • take 1 to 2 chewable tablets every 4-6 hours
    • do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
    children 6 to under 12 years
    • give ½ to 1 chewable tablet every 6-8 hours
    • do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
    children 2 to under 6 years
    • give ½ chewable tablet every 6-8 hours
    • do not give more than 1-½ chewable tablets in 24 hours, or as directed by a doctor
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  • Other information

    • Phenylketonurics: contains phenylalanine 0.84 mg per tablet
    • store at room temperature 68°-77°F (20°-25°C)
    • do not use if pouch is opened.
    • see bottom panel for lot number and expiration date
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  • Inactive ingredients

    anhydrous citric acid, aspartame, FD&C yellow 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

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  • Questions or comments ?

    Call 1-800-382-7219

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  • SPL UNCLASSIFIED SECTION

    Repackaged and distributed by:
    Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

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  • PRINCIPAL DISPLAY PANEL - 2 Tablet Carton

    #1
    Pharmacist
    Recommended
    Brand

    Dimenhydrinate
    Tablets/Antiemetic

    CHEWABLE FORMULA
    Dramamine®

    MOTION SICKNESS RELIEF

    DUAL ACTION

    1. TREATS SYMPTOMS
      ON THE SPOT
    2. PREVENTS NAUSEA,
      DIZZINESS & VOMITING

    Convenient
    Chewable Tablets

    2 ORANGE FLAVORED
    TABLETS
    (50 mg EACH)

    2 TABLETS

    Lil'
    Drug Store ®

    Principal Display Panel - 2 tablet carton
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  • INGREDIENTS AND APPEARANCE
    DRAMAMINE 
    dimenhydrinate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66715-9709(NDC:63029-902)
    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
    anhydrous citric acid  
    aspartame  
    FD&C yellow no. 6  
    aluminum oxide  
    magnesium stearate  
    maltodextrin  
    sorbitol  
    Product Characteristics
    Color ORANGE Score 2 pieces
    Shape ROUND (Circular Flat Faced Tablet) Size 12mm
    Flavor ORANGE Imprint Code DRAMAMINE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66715-9709-1 1 in 1 CARTON
    1 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 05/10/2010
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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