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NDC 10237-0942-25 Gravol 15 mg/5mL Details

Gravol 15 mg/5mL

Gravol is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is DIMENHYDRINATE.

MedlinePlus Drug Summary

Dimenhydrinate is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. Dimenhydrinate is in a class of medications called antihistamines. It works by preventing problems with body balance.

Related Packages: 10237-0942-25
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dimenhydrinate

Product Information

NDC	10237-0942
Product ID	10237-942_d955f3fa-a659-f7ef-e053-2a95a90aeb8f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Gravol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimenhydrinate
Product Type	HUMAN OTC DRUG
Dosage Form	SYRUP
Route	ORAL
Active Ingredient Strength	15
Active Ingredient Units	mg/5mL
Substance Name	DIMENHYDRINATE
Labeler Name	Church & Dwight Co., Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10237-0942-25 (10237094225)

Pricing Information	N/A
NDC Package Code	10237-942-25
Billing NDC	10237094225
Package	1 BOTTLE in 1 CARTON (10237-942-25) / 75 mL in 1 BOTTLE
Marketing Start Date	2022-03-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d955f612-1265-f1be-e053-2995a90a5345 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIMENHYDRINATE	15 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	03/02/2022

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

Name	Address	ID/FEI	Business Operations
Establishment
Church & Dwight Canada Corp.		253933600	manufacture(10237-942)

Revised: 3/2022

Document Id: d955f3fa-a659-f7ef-e053-2a95a90aeb8f

Set id: d955f612-1265-f1be-e053-2995a90a5345

Version: 1

Effective Time: 20220302