Label: GRAVOL- dimenhydrinate capsule, liquid filled

  • NDC Code(s): 10237-940-08
  • Packager: Church & Dwight Co., 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 March 7, 2022

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  • Active ingredient (in each Liquid Gel)

    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 liquid gels every 4-6 hours
    • do not take more than 8 liquid gels in 24 hours, or as directed by a doctor
    children 6 to under 12 years:
    • give 1 liquid gel every 6-8 hours
    • do not give more than 3 liquid gels 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

    Gelatin, glycerin, mannitol, polyethylene glycol 400, povidone, purified water, Red 33, sorbitan, sorbitol

  • 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

    Ages 6+

    Gravol™ LIQUID GELS

    Gravol™

    MOTION SICKNESS RELIEF

    Dimenhydrinate 50 mg - Antiemetic

    8

    LIQUID GELS

    (Liquid Filled

    Capsules)

    TASTE FREE

    EASY TO SWALLOW

    ABASE_2_QCPDF2129432_R8.jpg

  • 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 (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorpinkScorescore with uneven pieces
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33603/02/2022
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Canada Corp.253933600manufacture(10237-940)
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