GRAVOL- dimenhydrinate tablet, coated 
Church & Dwight Co., Inc.

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.

----------

Gravol™ Motion Sickness Relief - Coated Tablets

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Use

For prevention and treatment of these symptoms 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 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

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

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

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
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(10237-941)

Revised: 3/2022
Document Id: d9582385-ba46-eebc-e053-2a95a90af9fe
Set id: d95240bb-02f2-3226-e053-2995a90afacd
Version: 2
Effective Time: 20220303
 
Church & Dwight Co., Inc.