Dramamine

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2023-03-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:28

Label at a glance#

ProductDramamine
Active ingredientDIMENHYDRINATE
Label structure8 sections

Dosage and administration

to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity to prevent or treat motion sickness:  adults and children 12 years and over • take 1 to 2 chewable tablets every 4-6 hours  • do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor  children 6 to under 12 years • give 1/2 to 1 chewable tablet every 6-8 hours • do not give more than 3 chewable...

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 

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

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 1/2 to 1 hour before starting activity
to prevent or treat motion sickness:

 adults and children 12 years and over

• take 1 to 2 chewable tablets every 4-6 hours 

• do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor

 children 6 to under 12 years

• give 1/2 to 1 chewable tablet every 6-8 hours

• do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor

 children 2 to under 6 years

• give 1/2 chewable tablet every 6-8 hours

• do not give more than 1-1/2 chewable tablets in 24 hours, or as directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

• Phenylketonurics: contains phenylalanine 0.84 mg per tablet

• store at room temperature 20º-25ºC (68º- 77ºF)

• do not use if pouch is opened

• see pouch for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, aspartame, FD&C yellow 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-382-7219

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DramamaineDramamaine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198603dimenhyDRINATE 50 MG Oral TabletPSN3
201716Dramamine 50 MG Oral TabletPSN3
201716dimenhydrinate 50 MG Oral Tablet [Dramamine]SBD3
198603dimenhydrinate 50 MG Oral TabletSCD3
201716Dramamine 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-170-01Dramamine1 in 1 CARTONTABLET13
67751-170-01Dramamine2 in 1 POUCHTABLET23
67751-170-02Dramamine1 in 1 CARTONTABLET13
67751-170-02Dramamine4 in 1 POUCHTABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-170DRAMAMINE (DIMENHYDRINATE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]3Legacy NDC, 4 package rows20230316_4139b5bf-2e49-40c3-9f4a-d8e15c044ead.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-17067751-170-01, 67751-170-02
63029-901

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dramamine Original FormulaDIMENHYDRINATEMedtech Products Inc.f9302a5a-295a-4501-9332-e3f5eb3873622025-10-23WarningsExact identifier
ndc (product): 63029-901
f6f79a87-6831-c39d-e053-6394a90ae6294139b5bf-2e49-40c3-9f4a-d8e15c044ead2023-03-15WarningsExact identifier
spl id: f6f79a87-6831-c39d-e053-6394a90ae629
spl set id: 4139b5bf-2e49-40c3-9f4a-d8e15c044ead

Reported adverse events (FAERS/openFDA)#

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