GRAVOL- dimenhydrinate capsule, liquid filled

Gravol by

Drug Labeling and Warnings

Gravol by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Church & Dwight Canada Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Dimenhydrinate 50 mg

Purpose

antiemetic

Uses

For the prevention and treatment of the nausea, vomiting and dizziness associated with motion sickness

Warnings

Do not use for children under 6 years of age, unless directed by a doctor

Ask a doctor before use if you or your child has

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you or your child is taking a sedative or tranquilizer

When using this product

• may cause marked drowsiness
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health professional 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) rtght away.

Directions

To prevent motion sickness, the first dose should be taken ½ to 1 hour betore starting activity

• Adults and children 12 years of age and older: take 1 or 2 capsules every 4 to 6 hours. Do not exceed 8 capsules in 24 hours, or as directed by a doctor
• Children 6 to under 12 years of age: take 1 capsule every 6 to 8 hours. Do not exceed 3 capsules in 24 hours, or as directed by a doctor

Other Information

Store between 59° – 77°F

Inactive ingredients

D&C red 33, gelatin, glycerin, polyethylene glycol 400, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

Call us at 1-888-334-5387 M-F 9am-5pm ET

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton

Gravol™
MOTION SICKNESS
Dimenhydrinate capsules 50 mg

24
LIQUID GELS
(Liquid Filled
Capsules)

TASTE FREE
EASY TO SWALLOW

INGREDIENTS AND APPEARANCE

GRAVOL 
dimenhydrinate capsule, liquid filled

Product 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, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	PINK	Score	no score
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
2	NDC: 10237-940-24	3 in 1 CARTON	05/15/2024
2		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 DRUG	M009	03/02/2022

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Canada Corp		253933600	PACK(10237-940)