Gravol

Manufacturer
Church & Dwight Co., Inc. | Church & Dwight Canada Corp
Effective date
2024-05-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:55

Label at a glance#

ProductGravol
Active ingredientDIMENHYDRINATE
Label structure10 sections

Indications and uses

For the prevention and treatment of the nausea, vomiting and dizziness associated with motion sickness

Dosage and administration

To prevent motion sickness, the first dose should be taken ½ to 1 hour betore starting activity Adults and children 12 years of age and older: take 1 or 2 capsules every 4 to 6 hours. Do not exceed 8 capsules in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: take 1 capsule every 6 to 8 hours. Do not exceed 3 capsules in 24 hours, or as directed by a doctor

Storage and handling

Store between 59° – 77°F

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimenhydrinate 50 mg

Purpose

OTC - PURPOSE SECTION

antiemetic

Uses

INDICATIONS & USAGE SECTION

For the prevention and treatment of the nausea, vomiting and dizziness associated with motion sickness

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use for children under 6 years of age, unless directed by a doctor

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you or your child is taking a sedative or tranquilizer

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) rtght away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

  • Adults and children 12 years of age and older: take 1 or 2 capsules every 4 to 6 hours. Do not exceed 8 capsules in 24 hours, or as directed by a doctor
  • Children 6 to under 12 years of age: take 1 capsule every 6 to 8 hours. Do not exceed 3 capsules in 24 hours, or as directed by a doctor

Other Information

STORAGE AND HANDLING SECTION

Store between 59° – 77°F

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red 33, gelatin, glycerin, polyethylene glycol 400, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gravol™
MOTION SICKNESS
Dimenhydrinate capsules 50 mg

24
LIQUID GELS
(Liquid Filled
Capsules)

TASTE FREE
EASY TO SWALLOW

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309912dimenhyDRINATE 50 MG Oral CapsulePSN4
2594772Gravol 50 MG Oral CapsulePSN4
2594772dimenhydrinate 50 MG Oral Capsule [Gravol]SBD4
309912dimenhydrinate 50 MG Oral CapsuleSCD4
2594772Gravol 50 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-940-08Gravol1 in 1 CARTONCAPSULE, LIQUID FILLED14
10237-940-08Gravol8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84
10237-940-24Gravol8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84
10237-940-24Gravol3 in 1 CARTONCAPSULE, LIQUID FILLED34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-940GRAVOL (DIMENHYDRINATE) CAPSULE, LIQUID FILLED [CHURCH & DWIGHT CO., INC.]4Current NDC, Legacy NDC, 4 package rows20240524_d941705f-12a1-4757-e053-2995a90ad3fa.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-94010237-940-08, 10237-940-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d941705f-12a1-4757-e053-2995a90ad3fa2024-05-13WarningsExact identifier
ndc (package): 10237-940-08
ndc (package): 10237-940-24
ndc (product): 10237-940
ndc11 (package): 10237094024
ndc11 (package): 10237094008
spl id: 0f7eb768-a541-4459-86a5-45cb451cfb33
spl set id: d941705f-12a1-4757-e053-2995a90ad3fa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.