FDA.reportPublic FDA data

Dramamine Original Formula

Manufacturer
Medtech Products Inc.
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:41:38

Label at a glance#

ProductDramamine Original Formula
Active ingredientDIMENHYDRINATE
Label structure11 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 tables 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 ½ to 1 tablet every 6-8 hours do not give more than 3 tablets in 24 hours, or as directed by a...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

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 give to

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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 dizziness
  • 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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 tables 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 ½ 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 ½ tablet every 6-8 hours
  • do not give more than 1 ½ tablets
    in 24 hours, or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-382-7219

Dramamine.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dramamine®
motion sickness 
Original
Dimenhydrinate tablets/antiemetic
12 tablets (50 mg each)

Dramamine® motion sickness Original Dimenhydrinate tablets/antiemetic 12 tablets (50 mg each)Dramamine® motion sickness Original Dimenhydrinate tablets/antiemetic 12 tablets (50 mg each)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dramamine®
motion sickness
Original
Dimenhydrinate tablets/antiemetic
36 tablets (50 mg each)

A yellow label with a blue circle and white text AI-generated content may be incorrect.A yellow label with a blue circle and white text AI-generated content may be incorrect.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198603dimenhyDRINATE 50 MG Oral TabletPSN8
201716Dramamine 50 MG Oral TabletPSN8
201716dimenhydrinate 50 MG Oral Tablet [Dramamine]SBD8
198603dimenhydrinate 50 MG Oral TabletSCD8
201716Dramamine 50 MG Oral TabletSY8

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
63029-901-01Dramamine Original Formula12 in 1 BLISTER PACKTABLET128
63029-901-01Dramamine Original Formula3 in 1 BOXTABLET38
63029-901-02Dramamine Original Formula1 in 1 BOXTABLET18
63029-901-02Dramamine Original Formula12 in 1 BOTTLETABLET128
63029-901-03Dramamine Original Formula2 in 1 POUCHTABLET28
63029-901-03Dramamine Original Formula1 in 1 CARTONTABLET18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMENHYDRINATEACTIVE INGREDIENTJB937PER5C3
CHLORTHEOPHYLLINEACTIVE MOIETYGE2UA340FM3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMK3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH483
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-90163029-901-01, 63029-901-02, 63029-901-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMENHYDRINATEJB937PER5CACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72023-12-27full-release2026-06-01 00:06:36

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
Dramamine Original FormulaDIMENHYDRINATEMedtech Products Inc.f9302a5a-295a-4501-9332-e3f5eb3873622025-10-23WarningsExact identifier
ndc (package): 63029-901-02
ndc (package): 63029-901-01
ndc (package): 63029-901-03
ndc (product): 63029-901
ndc11 (package): 63029090103
ndc11 (package): 63029090101
ndc11 (package): 63029090102
spl id: 23845de1-5d17-4310-83f5-ba7382003922
spl set id: f9302a5a-295a-4501-9332-e3f5eb387362

Reported adverse events (FAERS/openFDA)#

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