Label: DIMENHYDRINATE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 6, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredient (in each tablet)

    Dimenhydrinate 50 mg

  • PURPOSE

    Purpose

    Antiemetic

  • Uses

    for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

  • WARNINGS

    Do not give to children under 2 years of age unless directed by a doctor

    Ask a doctor before use if you have

    ■ glaucoma

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ 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

    ■ use caution when driving a motor vehicle or operating machinery

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

    .

    Keep out of reach of children.

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

  • Directions

    ■ to prevent motion sickness, the rst dose should be taken one-half to one hour before starting activity

    adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor

    children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor

    children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

  • Other information

    ■ each tablet contains: calcium 30 mg

    ■ store in a dry place at 15° – 30°C (59° – 86°F)

    ■ protect from moisture

    ■ see end -ap for expiration date and lot number

    TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • INACTIVE INGREDIENT

    croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine®.

    Distributed by: MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268
    Questions or comments?
    Call (800) 616-2471
    www.majorpharmaceuticals.com

  • PRINCIPAL DISPLAY PANEL

    MAJOR ®

    NDC 0904-6772-12

    Compare to the Active Ingredient in DRAMAMINE ® Original Formula*

    Driminate TM

    Dimenhydrinate USP, Antiemetic

    For Nausea, Dizziness and Vomiting from Motion Sickness

    12 Tablets 50mg Each

    Use as Directed

    Major Label

  • INGREDIENTS AND APPEARANCE
    DIMENHYDRINATE 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6772
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code 1006;1006
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6772-121 in 1 CARTON02/14/2019
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00902/14/2019
    Labeler - Major Pharmaceuticals (191427277)