DRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]

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DRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]
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NDC 63029-901-01, 63029-901-02
Set ID f9302a5a-295a-4501-9332-e3f5eb387362
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

    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 dizziness
    • 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

    • store at room temperature 68-77ºF (20-25ºC)
    • do not use if carton is open or if blister unit is broken or torn
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose

  • Questions or comments?

    Call 1-800-382-7219

  • PRINCIPAL DISPLAY PANEL


    ORIGINAL FORMULA

    Dramamine®
    Dimenhydrinate Tablets/Antiemetic

    MOTION SICKNESS RELIEF

    12 Tablets (50 mg EACH)

    ORIGINAL FORMULA

    Dramamine®
    Dimenhydrinate Tablets/Antiemetic

    MOTION SICKNESS RELIEF 


    36 Tablets (50 mg EACH)

    PRINCIPAL DISPLAY PANEL ORIGINAL FORMULA Dramamine® Dimenhydrinate Tablets/Antiemetic MOTION SICKNESS RELIEF 12 Tablets (50 mg EACH) ORIGINAL FORMULA Dramamine® Dimenhydrinate Tablets/Antiemetic MOTION SICKNESS RELIEF 36 Tablets (50 mg EACH)

    PRINCIPAL DISPLAY PANEL ORIGINAL FORMULA Dramamine® Dimenhydrinate Tablets/Antiemetic MOTION SICKNESS RELIEF 12 Tablets (50 mg EACH) ORIGINAL FORMULA Dramamine® Dimenhydrinate Tablets/Antiemetic MOTION SICKNESS RELIEF 36 Tablets (50 mg EACH)

  • INGREDIENTS AND APPEARANCE
    DRAMAMINE ORIGINAL FORMULA 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-901
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeROUNDSize8mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-901-013 in 1 BOX01/15/2012
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63029-901-021 in 1 BOX01/15/2012
    212 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:63029-901-031 in 1 CARTON01/15/2012
    32 in 1 POUCH; 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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