Search by Drug Name or NDC

NDC 10237-0940-08 Gravol 50 mg/1 Details

Gravol 50 mg/1

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

Product Information

NDC	10237-0940
Product ID	10237-940_d9a20e59-9657-7032-e053-2a95a90a8b46
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	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
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 10237-0940-08 (10237094008)

Pricing Information	N/A
NDC Package Code	10237-940-08
Billing NDC	10237094008
Package	1 BLISTER PACK in 1 CARTON (10237-940-08) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2022-03-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d941705f-12a1-4757-e053-2995a90ad3fa Details

Active ingredient (in each Liquid Gel)

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 liquid gels every 4-6 hours do not take more than 8 liquid gels in 24 hours, or as directed by a doctor
children 6 to under 12 years:	give 1 liquid gel every 6-8 hours do not give more than 3 liquid gels 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

Gelatin, glycerin, mannitol, polyethylene glycol 400, povidone, purified water, Red 33, sorbitan, sorbitol

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

Ages 6+

Gravol™ LIQUID GELS

Gravol™

MOTION SICKNESS RELIEF

Dimenhydrinate 50 mg - Antiemetic

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIMENHYDRINATE	50 mg

Ingredient Name	Strength
Inactive Ingredients
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	pink	Score	score with uneven pieces
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10237-940-08	1 in 1 CARTON	03/02/2022
1		8 in 1 BLISTER PACK; 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(10237-940)

Revised: 3/2022

Document Id: d9a20e59-9657-7032-e053-2a95a90a8b46

Set id: d941705f-12a1-4757-e053-2995a90ad3fa

Version: 3

Effective Time: 20220307