Label: GRAVOL- dimenhydrinate tablet, coated
- NDC Code(s): 10237-941-10
- 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 3, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
-
Warnings
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
- a breathing problem such as emphysema or chronic bronchitis
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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
- Inactive ingredients
- Questions or comments?
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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
-
INGREDIENTS AND APPEARANCE
GRAVOL
dimenhydrinate tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-941 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength 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 Color orange Score 4 pieces Shape ROUND Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-941-10 1 in 1 CARTON 03/02/2022 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 03/02/2022 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Canada Corp. 253933600 manufacture(10237-941)