Label: MOTION SICKNESS RELIEF- dimenhydrinate tablet

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

Drug Label Information

Updated January 10, 2024

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  • 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • 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
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages

    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 over1 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    		½ 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    		½ tablet every 6-8 hours; do not
    exceed 1½ 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 or comments?

    1-888-423-0139

  • Principal display panel

    TopCare®
                health™

    NDC 36800-930-12

    COMPARE TO DRAMAMINE® ORIGINAL
    FORMULA ACTIVE INGREDIENT*

    ORIGINAL FORMULA
    Motion Sickness Relief
    DIMENHYDRINATE, 50 mg - ANTIEMETIC

    Prevents Nausea, Dizziness & Vomiting

    12 TABLETS

    For Children & Adults

    actual size

    *This product is not manufactured or distributed by Medtech
    Products Inc., owner of the registered trademark Dramamine®
    Original Formula.          50844    REV0518B19802

    DISTRIBUTED BY TOPCO ASSOCIATES LLC,
    ELK GROVE VILLAGE, IL 60007
    ©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139
    topcare@topco.com www.topcarebrand.com

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

    TopCare 44-198

    TopCare 44-198

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-930
    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:36800-930-122 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 - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(36800-930)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(36800-930) , pack(36800-930)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(36800-930)
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