Gravol™ Motion Sickness Relief - Coated Tablets

Manufacturer
Church & Dwight Co., Inc. | Church & Dwight Canada Corp
Effective date
2022-03-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:12:39

Label at a glance#

ProductGravol
Active ingredientDIMENHYDRINATE
Label structure9 sections

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dimenhydrinate 50 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Use

INDICATIONS & USAGE SECTION

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

  • nausea
  • vomiting
  • dizziness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

ABASE_2_QCPDF2129431_R8.jpgABASE_2_QCPDF2129431_R8.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198603dimenhyDRINATE 50 MG Oral TabletPSN3
2594774Gravol 50 MG Oral TabletPSN3
2594774dimenhydrinate 50 MG Oral Tablet [Gravol]SBD3
198603dimenhydrinate 50 MG Oral TabletSCD3
2594774Gravol 50 MG Oral TabletSY3

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
10237-941-10Gravol10 in 1 BLISTER PACKTABLET, COATED103
10237-941-10Gravol1 in 1 CARTONTABLET, COATED13
10237-941-30Gravol3 in 1 CARTONTABLET, COATED33
10237-941-30Gravol10 in 1 BLISTER PACKTABLET, COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-941GRAVOL (DIMENHYDRINATE) TABLET, COATED [CHURCH & DWIGHT CO., INC.]3Current NDC, Legacy NDC, 4 package rows20240517_d95240bb-02f2-3226-e053-2995a90afacd.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-94110237-941-10, 10237-941-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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.d95240bb-02f2-3226-e053-2995a90afacd2022-03-03WarningsExact identifier
ndc (package): 10237-941-30
ndc (package): 10237-941-10
ndc (product): 10237-941
ndc11 (package): 10237094110
ndc11 (package): 10237094130
spl id: ff55ed07-d94e-467a-b8cf-f7a00ecdae4c
spl set id: d95240bb-02f2-3226-e053-2995a90afacd

Reported adverse events (FAERS/openFDA)#

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