FDA.reportPublic FDA data

Dimenhydrinate

Manufacturer
Major Pharmaceuticals
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:12:10

Label at a glance#

ProductDimenhydrinate
Active ingredientDIMENHYDRINATE
Label structure10 sections

Indications and uses

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

Dosage and administration

■ to prevent motion sickness, the rst dose should be taken one-half to one hour before starting activity ■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age : 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor ■ children 2 to under 6 years o...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not give to children under 2 years of age unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

■ marked drowsiness may occur

■ avoid alcoholic drinks

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ 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.

OVERDOSAGE SECTION

In case of 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 rst dose should be taken one-half to one hour before starting activity

■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor

■ children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor

■ children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

■ each tablet contains: calcium 30 mg

■ store in a dry place at 15° – 30°C (59° – 86°F)

■ protect from moisture

■ see end -ap for expiration date and lot number

■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine®.

Distributed by: MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR ®

NDC 0904-6772-12

Compare to the Active Ingredient in DRAMAMINE ® Original Formula*

Driminate TM

Dimenhydrinate USP, Antiemetic

For Nausea, Dizziness and Vomiting from Motion Sickness

12 Tablets 50mg Each

Use as Directed

Major LabelMajor Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198603dimenhyDRINATE 50 MG Oral TabletPSN4
198603dimenhydrinate 50 MG Oral TabletSCD4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6772-12Dimenhydrinate12 in 1 BLISTER PACKTABLET124
0904-6772-12Dimenhydrinate1 in 1 CARTONTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6772-12EA - Each0904-6772d09bf812-9a2f-4a7e-bfcd-054e62f3ffd712019-05-02

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-67720904-6772-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMENHYDRINATEJB937PER5CACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
DimenhydrinateDIMENHYDRINATEMajor Pharmaceuticals78d22836-a442-7c0c-e053-2991aa0a62f32025-08-13WarningsExact identifier
ndc (package): 0904-6772-12
ndc (product): 0904-6772
ndc11 (package): 00904677212
spl id: 3c44729b-0a55-8eaf-e063-6394a90a5ba4
spl set id: 78d22836-a442-7c0c-e053-2991aa0a62f3

Reported adverse events (FAERS/openFDA)#

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