Label: GRAVOL CHEWABLES MOTION SICKNESS DIMENHYDRINATE- dimenhydrinate tablet, chewable

  • NDC Code(s): 10237-943-08
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dimenhydrinate 50 mg

  • Purpose

    antiemetic

  • Uses

    For the prevention and treatment of the nausea, vomiting and 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 or your child has

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor before use if you or your child is taking a sedative or tranquilizer

    When using this product

    • may cause marked drowsiness
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • 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 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 ½ to 1 hour before starting activity

    • Adults and children 12 years of age and older: take 1 to 2 tablets every 4 to 6 hours. Do not exceed 8 tablets in 24 hours, or as directed by a doctor
    • Children 6 to under 12 years of age: take ½ to 1 tablet every 6 to 8 hours. Do not exceed 3 tablets in 24 hours, or as directed by a doctor
    • Children 2 to under 6 years of age: give ½ tablet every 6-8 hours. Do not give more than 1 ½ tablets in 24 hours, or as directed by a doctor
  • Other information

    • Phenylketunurics: contains phenylalanine 15 mg per tablet
    • Store between 59° - 77°F
  • Inactive ingredients

    acetylated monoglycendes, amino methacrylate copolymer, aspartame, citric acid, com starch, ethylcellulose, FD&C yellow 6 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, polyethylene glycol

  • Questions or comments?

    Call us at 1-888-334--5387 M-F 9am-5pm ET

  • PRINCIPAL DISPLAY PANEL - 50 mg Blister Pack Carton

    Prevents and Treats:
    Nausea, Vomiting
    & Dizziness*

    *Prevention and treatment of nausea,
    vomiting and dizziness due to motion sickness

    Gravol™ CHEWABLES

    Gravol™
    MOTION SICKNESS
    Dimenhydrinate tablets 50 mg

    8
    TABLETS

    ORANGE
    FLAVOR

    PRINCIPAL DISPLAY PANEL - 50 mg Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GRAVOL CHEWABLES MOTION SICKNESS DIMENHYDRINATE 
    dimenhydrinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-943
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeROUNDSize14mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-943-081 in 1 CARTON04/01/2024
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00904/01/2024
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Canada Corp253933600MANUFACTURE(10237-943)
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