DRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]

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DRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]
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NDC 63029-902-01, 63029-902-02, 63029-902-04
Set ID 76166156-bce1-492f-833e-6bbd07859c3f
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class
Product Number
Application Number PART336
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each tablet)

    Dimenhydrinate 50 mg

  • Purpose

    Antiemetic

  • Use

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

    • nausea
    • vomiting
    • dizziness
  • WARNINGS

    Warnings

    Do not give to

    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

    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.

  • Directions

    • to prevent motion sickness, the first dose should be taken ½ 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 tables every 4-6 hours
    • do not take more than 8 tablets in 24 hours, or as directed by a doctor
    Children 6 to
    under 12 years
    • give ½ to 1 tablet every 6-8 hours
    • do not give more than 3 tablets in 24 hours, or as directed by a doctor
    Children 2 to
    under 6 years
    • give ½ tablet every 6-8 hours
    • do not give more than 1 ½ tablets in 24 hours, or as directed by a doctor

  • Other Information

    • Phenylketonurics: contains phenylalanine 0.75 mg per tablet
    • store at room temperature 20-25ºC (68-77ºF)
    • see side panel for lot number and expiration date
    • Tamper Evident: Do not use if pouch is torn or open.

    • do not use if carton is opened or if blister is broken or torn

  • Inactive ingredients

    anhydrous citric acid, aspartame, FD&C yellow no. 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified food starch, sorbitol

  • Questions?

    Call 1-800-382-7219

  • Dramamine® Chewable Orange Motion Sickness Relief, 8 ct

    Dramamine Chewable Orange 8 ct Carton

  • Dramamine® Chewable Orange Motion Sickness Relief, 4 ct

    Dramamine Chewable Orange 4 ct Carton

  • INGREDIENTS AND APPEARANCE
    DRAMAMINE ORANGE 
    dimenhydrinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-902
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-902-011 in 1 BOX01/15/2012
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63029-902-022 in 1 POUCH; Type 0: Not a Combination Product01/15/2012
    3NDC:63029-902-041 in 1 BOX03/30/2013
    34 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33601/15/2012
    Labeler - Medtech Products Inc. (122715688)
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