GRAVOL- dimenhydrinate syrup

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]

Active ingredient (in each 5 mL)

Dimenhydrinate 15 mg

Purpose

Antiemetic

Use

For prevention and treatment of these symptoms associated with motion sickness:

• nausea
  
• vomiting
  
• dizziness

Warnings

Do not use

for children under 2 years of age unless directed by a doctor.

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

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase dizziness
• be careful when driving a motor vehicle or operating machinery or any activity that requires alertness

If pregnant or breast-feeding,

ask a doctor 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
• 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

• store at room temperature 59º-77ºF (15º-25ºC)
• do not use if packet is torn

Inactive ingredients

Citric acid, flavor, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucrose, water

Questions or comments?

1-800-952-5080 M-F 9am to 5pm ET

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

INGREDIENTS AND APPEARANCE

GRAVOL 
dimenhydrinate syrup

Product 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)