Label: MOTION SICKNESS RELIEF- dimenhydrinate tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 27, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each tablet)

    Dimenhydrinate 50 mg 

  • Purpose

    Antiemetic 

  • Uses

    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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the 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 beverages
    • 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 right away. 

  • Directions

    • to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity
    adults and children
    12 years and over
    1 to 2 tablets every 4-6 hours;
    do not exceed 8 tablets in 24 hours,
    or as directed by a doctor
    children 6 to under
    12 years
    1/2 to 1 tablet every 6-8 hours;
    do not exceed 3 tablets in 24 hours,
    or as directed by a doctor
    children 2 to under
    6 years
    1/2 tablet every 6-8 hours;
    do not exceed 1 1/2 tablets in 24 hours,
    or as directed by a doctor

  • Other information

    • each tablet contains: calcium 35 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

  • Questions?

    Call 1-800-824-1706 Monday - Friday 9am - 4pm MST 

  • Principal Display Panel

    WinCo®
    FOODS

    *Compare to the active ingredient
    in DRAMAMINE® Original Formula

    Motion Sickness
    Relief

    DIMENHYDRINATE 50 mg / ANTIEMETIC

    12
    Tablets

    DISTRIBUTED BY:
    WINCO FOODS, LLC, BOISE, ID 83704

    50844     REV0518B19802   WF1810

    *This product is not manufactured or distributed by
    MEDTECH PRODUCTS INC., distributor of
    DRAMAMINE® Original Formula.

    The Supermarket Low Price Leader®
    100% SATISFACTION GUARANTEE

    Comments & Questions?
    800-824-1706 www.wincofoods.com

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
    OPENED OR IF BLISTER UNIT IS TORN, BROKEN
    OR SHOWS ANY SIGNS OF TAMPERING

     

    Winco 44-198

    Winco 44-198

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, 8-CHLOROTHEOPHYLLINE - 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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code 44;198
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-118-122 in 1 CARTON12/01/1992
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00912/01/1992
    Labeler - WinCo Foods, LLC (056098817)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(67091-118)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(67091-118) , pack(67091-118)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(67091-118)