Label: MOTION SICKNESS- dimenhydrinate tablet

  • NDC Code(s): 11673-198-02, 11673-198-08
  • Packager: Target Corporation
  • 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 March 5, 2022

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 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 (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 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 years½ 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 years½ 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 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 1-800-910-6874

  • Principal Display Panel

    NDC 11673-198-08

    Compare to active ingredient in
    Dramamine® Original Formula*

    motion sickness relief
    dimenhydrinate 50 mg/antiemetic

    up&up

    helps prevent nausea, dizziness and vomiting
    from motion sickness

    for adults and children

    ACTUAL SIZE

    24
    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    REV0518D19808

    094 01 0726 R04 ID225401
    Distributed by Target Corporation
    Minneapolis, MN 55403
    ©2018 Target Brands, Inc.
    Shop Target.com

    Target 44-198

    Target 44-198

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-198
    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)  
    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:11673-198-084 in 1 CARTON12/01/1992
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11673-198-022 in 1 CARTON12/01/1992
    26 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 - Target Corporation (006961700)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(11673-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(11673-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(11673-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(11673-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(11673-198)