Label: GRAVOL- dimenhydrinate syrup

  • NDC Code(s): 10237-942-25
  • 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 2, 2022

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

View All Sections
  • Active ingredient (in each 5 mL)

    Dimenhydrinate 15 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:

    children 2 to 6 years
    • take 1 teaspoon (5 mL) every 4-6 hours
    • do not take more than 5 teaspoons (25 mL) in 24 hours, or as directed by a doctor
    children 6 to under 12 years
    • give 2 teaspoons (10 mL) every 6-8 hours
    • do not give more than 10 teaspoons (50 mL) 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

    Citric acid, flavor, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucrose, water

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    OVER 70 YEARS OF

    QUALITY & TRUST†

    Children 2+

    Prevents and Treats:

    Nausea & Vomiting

    Dizziness*

    kids Gravol™

    MOTION SICKNESS RELIEF

    Dimenhydrinate 15 mg Syrup - Antiemetic

    *Prevention and treatment of

    nausea, vomiting and dizziness

    due to motion sickness

    MIXED FRUIT

    FLAVOR

    DYE FREE ALCOHOL FREE

    2.5 FL OZ (75 mL)

    Church & Dwight Co., Inc.,

    Ewing, NJ 08628

    Gravol is a trademark of

    Church & Dwight Canada Corp.

    Made in Canada

    GRFC-00164-01 72022778

    ABASE_2_QCPDF2129433_R6.jpg

  • INGREDIENTS AND APPEARANCE
    GRAVOL 
    dimenhydrinate syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-942
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCROSE (UNII: C151H8M554)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-942-251 in 1 CARTON03/02/2022
    175 mL in 1 BOTTLE; 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(10237-942)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!