Label: MOTION SICKNESS- dimenhydrinate tablet

  • NDC Code(s): 50804-198-02
  • Packager: Geiss, Destin & Dunn 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 February 26, 2020

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

    • 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 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 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?

    1-800-426-9391

  • Principal display panel

    GoodSense®

    NDC 50804-198-02

    Original Formula

    Motion Sickness
    Dimenhydrinate 50 mg
    Antiemetic

    Prevents Nausea, Vomiting & Dizziness
    for Children & Adults

    12 Tablets

    actual size

    *Compare to the active ingredient in
    Dramamine® Original Formula

    100%
    SATISFACTION
    GUARANTEED

    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         ORG051819802

    Distributed by: Geiss, Destin & Dunn, Inc., A Perrigo Company
    Peachtree City, GA 30269
    www.PerrigoDirect.com
    (1-800-426-9391)
    GoodSense® is a registered trademark of L. Perrigo Company.

    GoodSense 44-198

    GoodSense 44-198

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-198
    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:50804-198-022 in 1 CARTON04/07/2020
    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 FINALpart33604/07/2020
    Labeler - Geiss, Destin & Dunn Inc. (076059836)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(50804-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(50804-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(50804-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(50804-198)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(50804-198)