Label: DIMENHYDRINATE tablet

  • 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 October 22, 2018

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 29 mg

    ■ store at 25°C (77°F); excursions permitted between 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?

    1-800-616-2471

  • SPL UNCLASSIFIED SECTION

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    *This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Tablets.

    Distributed by: MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152 USA

  • 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

    1006-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 finalpart33602/14/2019
    Labeler - Major Pharmaceuticals (191427277)