Label: DRAMAMINE- 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 March 15, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient (in each tablet)

    Dimenhydrinate 50 mg

    Purpose

    Antiemetic

  • Use

    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
    • trouble urinating due to an enlarged 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 drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    ask a doctor before use.

    Keep out of reach of children.

    In case of accidental 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 1/2 to 1 hour before starting activity
    to prevent or treat motion sickness:

     adults and children 12 years and over

    • take 1 to 2 chewable tablets every 4-6 hours 

    • do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor

     children 6 to under 12 years

    • give 1/2 to 1 chewable tablet every 6-8 hours

    • do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor

     children 2 to under 6 years

    • give 1/2 chewable tablet every 6-8 hours

    • do not give more than 1-1/2 chewable tablets in 24 hours, or as directed by a doctor

  • Other information

    Phenylketonurics: contains phenylalanine 0.84 mg per tablet

    • store at room temperature 20º-25ºC (68º- 77ºF)

    • do not use if pouch is opened

    • see pouch for lot number and expiration date

  • Inactive ingredients

    anhydrous citric acid, aspartame, FD&C yellow 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

  • Questions or comments?

    call 1-800-382-7219

  • Package Labeling:

    Dramamaine

  • INGREDIENTS AND APPEARANCE
    DRAMAMINE 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-170(NDC:63029-901)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScore2 pieces
    ShapeROUNDSize8mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-170-011 in 1 CARTON09/23/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67751-170-021 in 1 CARTON09/23/2016
    24 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33609/23/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-170) , repack(67751-170)