Label: MOTION SICKNESS- 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 August 23, 2019

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  • Active ingredient (in each tablet)

    Dimenhydrinate 50 mg

  • Purpose

    Antiemetic

  • Uses

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

  • 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

    • 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
    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

    • protect from moisture
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

  • Questions or comments?

    1-800-426-9391
  • Principal Display Panel

    CORE VALUES™

    Compare to active ingredient in
    Dramamine® Original Formula

    NDC 63940-198-02

    Motion Sickness
    Dimenhydrinate 50 mg   Antiemetic
    Fast Acting Relief of Motion Sickness

    Actual Size

    12 tablets

    TAMPER EVIDENT: Use Only if This Blister is Intact

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

    50844    REV1115A19802

    Satisfaction Guaranteed
    Or Your Money Back
    Visit us at www.facevalues.com

    Distributed by:
    Liberty Procurement, Inc., 650 Liberty Ave., Union, NJ 07083 U.S.A.

    Core Values 44-198

    Core Values 44-198

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-198
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code 44;198
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-198-021 in 1 PACKAGE12/01/1992
    112 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33612/01/1992
    Labeler - Harmon Store Inc. (804085293)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(63940-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(63940-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(63940-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(63940-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(63940-198)