Label: GRAVOL- dimenhydrinate capsule, liquid filled

  • NDC Code(s): 10237-940-08, 10237-940-24
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 13, 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 6 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) rtght away.

  • Directions

    To prevent motion sickness, the first dose should be taken ½ to 1 hour betore starting activity

    • Adults and children 12 years of age and older: take 1 or 2 capsules every 4 to 6 hours. Do not exceed 8 capsules in 24 hours, or as directed by a doctor
    • Children 6 to under 12 years of age: take 1 capsule every 6 to 8 hours. Do not exceed 3 capsules in 24 hours, or as directed by a doctor
  • Other Information

    Store between 59° – 77°F

  • Inactive ingredients

    D&C red 33, gelatin, glycerin, polyethylene glycol 400, povidone, purified water, sorbitol sorbitan solution

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton

    Gravol™
    MOTION SICKNESS
    Dimenhydrinate capsules 50 mg

    24
    LIQUID GELS
    (Liquid Filled
    Capsules)

    TASTE FREE
    EASY TO SWALLOW

    PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GRAVOL 
    dimenhydrinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-940
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-940-081 in 1 CARTON03/02/2022
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:10237-940-243 in 1 CARTON05/15/2024
    28 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 Corp253933600PACK(10237-940)
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