Label: GRAVOL- dimenhydrinate tablet, coated

  • NDC Code(s): 10237-941-10, 10237-941-30
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 3, 2022

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  • 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 dizziness
    • be careful when driving a motor vehicle or operating machinery or any activity that requires alertness

    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 ½ to 1 hour before starting activity
    • to prevent or treat motion sickness, see below:
    adults and children 12 years and over:
    • take 1 to 2 tablets every 4-6 hours
    • do not take more than 8 tablets in 24 hours, or as directed by a doctor
    children 6 to under 12 years:
    • give 1/2 to 1 tablet every 6-8 hours
    • do not give more than 3 tablets in 24 hours, or as directed by a doctor
    children 2 to under 6 years:
    • give 1/4 to 1/2 tablet every 6-8 hours
    • do not give more than 1-1/2 tablets in 24 hours, or as directed by a doctor

  • Other information

    • store at room temperature 59º-77ºF (15º-25ºC)
    • do not use if packet is torn
  • Inactive ingredients

    Corn starch, croscarmellose sodium, FD&C yellow 6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

  • Questions or comments?

    1-800-952-5080 M-F 9am to 5pm ET

  • PRINCIPAL DISPLAY PANEL

    OVER 70 YEARS OF

    QUALITY & TRUST†

    Prevents and Treats:

    Nausea & Vomiting

    Dizziness*

    *Prevention and treatment of nausea,

    vomiting and dizziness due to motion sickness

    Gravol™ COATED TABLETS

    Gravol™

    MOTION SICKNESS RELIEF

    Dimenhydrinate 50 mg Tablets - Antiemetic

    10

    COATED TABLETS

    TASTE FREE

    EASY TO SWALLOW

    ABASE_2_QCPDF2129431_R8.jpg

  • INGREDIENTS AND APPEARANCE
    GRAVOL 
    dimenhydrinate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-941
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE (UNII: 029TFK992N)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGEScore4 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-941-101 in 1 CARTON03/02/2022
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:10237-941-303 in 1 CARTON05/15/2024
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00903/02/2022
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Canada Corp253933600MANUFACTURE(10237-941) , PACK(10237-941)
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