Label: MOTION SICKNESS RELIEF- dimenhydrinate tablet

  • NDC Code(s): 63868-034-12, 63868-034-24
  • Packager: CHAIN DRUG MARKETING ASSOCIATION 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 September 12, 2022

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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

    • 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

    • 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?

    1-800-426-9391

  • Principal Display Panel

    NDC 63868-034-12

    QC®
    QUALITY
    CHOICE

    Compare to the
    Active Ingredient in
    DRAMAMINE® ORIGINAL FORMULA*

    Motion Sickness Relief
    Original Formula
    Dimenhydrinate 50 mg | Antiemetic

    Prevents: Nausea, Vomiting & Dizziness
    for Children & Adults

    actual
    size

    24 Tablets

    *This product is not manufactured or distributed by
    Medtech Products Inc., owner of the registered trademark
    Dramamine® Original Formula.
    50844     REV0518B19808

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

    100% QC
    SATISFACTION
    GUARANTEED

    Distributed by C.D.M.A., Inc.©
    43157 W 9 Mile Rd
    Novi, MI 48375
    www.qualitychoice.com
    Questions: 248-449-9300


     Quality Choice 44-198

    Quality Choice 44-198

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-034
    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:63868-034-244 in 1 CARTON12/01/1992
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63868-034-122 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 - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(63868-034)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(63868-034)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(63868-034)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(63868-034)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(63868-034)
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