Label: DRAMAMINE ORIGINAL FORMULA- dimenhydrinate tablet

  • NDC Code(s): 63029-901-01, 63029-901-02, 63029-901-03
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 5, 2020

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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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