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
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- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- Purpose
- Use
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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:
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
- Inactive ingredients
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
GRAVOL
dimenhydrinate syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-942 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 15 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-942-25 1 in 1 CARTON 03/02/2022 1 75 mL in 1 BOTTLE; 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(10237-942)