GRAVOL CHEWABLES MOTION SICKNESS DIMENHYDRINATE- dimenhydrinate tablet, chewable

Gravol Chewables Motion Sickness Dimenhydrinate by

Drug Labeling and Warnings

Gravol Chewables Motion Sickness Dimenhydrinate 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 2 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) right away.

Directions

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

• Adults and children 12 years of age and older: take 1 to 2 tablets every 4 to 6 hours. Do not exceed 8 tablets in 24 hours, or as directed by a doctor
• Children 6 to under 12 years of age: take ½ to 1 tablet every 6 to 8 hours. Do not exceed 3 tablets in 24 hours, or as directed by a doctor
• Children 2 to under 6 years of age: give ½ tablet every 6-8 hours. Do not give more than 1 ½ tablets in 24 hours, or as directed by a doctor

Other information

• Phenylketunurics: contains phenylalanine 15 mg per tablet
• Store between 59° - 77°F

Inactive ingredients

acetylated monoglycendes, amino methacrylate copolymer, aspartame, citric acid, com starch, ethylcellulose, FD&C yellow 6 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, polyethylene glycol

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 50 mg Blister Pack Carton

Prevents and Treats:
Nausea, Vomiting
& Dizziness*

*Prevention and treatment of nausea,
vomiting and dizziness due to motion sickness

Gravol™ CHEWABLES

Gravol™
MOTION SICKNESS
Dimenhydrinate tablets 50 mg

8
TABLETS

ORANGE
FLAVOR

INGREDIENTS AND APPEARANCE

GRAVOL CHEWABLES MOTION SICKNESS DIMENHYDRINATE 
dimenhydrinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-943
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
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STARCH, CORN (UNII: O8232NY3SJ)
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	ORANGE	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-943-08	1 in 1 CARTON	04/01/2024
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 DRUG	M009	04/01/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Canada Corp		253933600	MANUFACTURE(10237-943)