GRAVOL- dimenhydrinate tablet, coated

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 tablet)

Dimenhydrinate 50 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:

• adults and children 12 years and over:
  • take 1 to 2 tablets every 4-6 hours
  • do not take more than 8 tablets in 24 hours, or as directed by a doctor
• children 6 to under 12 years:
  • give 1/2 to 1 tablet every 6-8 hours
  • do not give more than 3 tablets in 24 hours, or as directed by a doctor
• children 2 to under 6 years:
  • give 1/4 to 1/2 tablet every 6-8 hours
  • do not give more than 1-1/2 tablets 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

Corn starch, croscarmellose sodium, FD&C yellow 6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

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

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

Gravol™ COATED TABLETS

Gravol™

MOTION SICKNESS RELIEF

Dimenhydrinate 50 mg Tablets - Antiemetic

10

COATED TABLETS

TASTE FREE

EASY TO SWALLOW

INGREDIENTS AND APPEARANCE

GRAVOL 
dimenhydrinate tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-941
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE (UNII: 029TFK992N)
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	ORANGE	Score	4 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-941-10	1 in 1 CARTON	03/02/2022
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 10237-941-30	3 in 1 CARTON	05/15/2024
2		10 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	MANUFACTURE(10237-941) , PACK(10237-941)