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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- Official Label (Printer Friendly)
- Active ingredient (in each Liquid Gel)
- 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 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
- 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
Ages 6+
Gravol™ LIQUID GELS
Gravol™
MOTION SICKNESS RELIEF
Dimenhydrinate 50 mg - Antiemetic
8
LIQUID GELS
(Liquid Filled
Capsules)
TASTE FREE
EASY TO SWALLOW
-
INGREDIENTS AND APPEARANCE
GRAVOL
dimenhydrinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-940 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 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 Color pink Score score with uneven pieces Shape CAPSULE Size 15mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-940-08 1 in 1 CARTON 03/02/2022 1 8 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(10237-940)