Label: MOTION SICKNESS- dimenhydrinate tablet

  • NDC Code(s): 64092-600-12
  • Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, 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 August 17, 2019

If you are a consumer or patient 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to an enlargement of the prostate gland 

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • marked drowsiness may occur
    • 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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º- 86ºF)
    • 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?

    Call 1-800-426-9391

  • Principal Display Panel

    HEALTHCARE™

    NDC 64092-600-12

    *Compare to the active ingredient
    in Dramamine® Original Formula

    Motion Sickness
    Dimenhydrinate, 50 mg Each

    Antiemetic

    Prevents:
    • Nausea    • Dizziness    • Vomiting
    From Motion Sickness

    12 TABLETS

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

    *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® Original Formula.
    50844  REV0518G19802

    Distributed by:
    Great Lakes Wholesale & Marketing L.L.C.
    3729 Patterson Ave., S.E.
    Grand Rapids, MI 49512   www.glwholesale.com

    HEALTHCARE GUARANTEE
    If you are not completely satisfied with this
    product, regardless of reason, return your unused
    portion to Great Lakes Wholesale for a full refund

    Healthcare 44-198

    Healthcare 44-198

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-600
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code 44;198
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-600-122 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 FINALpart33612/01/1992
    Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(64092-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(64092-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(64092-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(64092-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(64092-600)