Dramamine

Manufacturer
Select Corporation
Effective date
2022-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:13

Label at a glance#

ProductDramamine
Active ingredientDIMENHYDRINATE
Label structure11 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, see below: 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...

Storage and handling

Phenylketonurics: contains phenylaline 0.84 mg per tablet store at room tempurature 20°- 25°C (68°-77°F) do not use if pouch is opened see bottom of this panel for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 give to 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor 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) immediately.

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, see below:
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 1½ chewable tablets in 24 hours, or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • Phenylketonurics: contains phenylaline 0.84 mg per tablet
  • store at room tempurature 20°- 25°C (68°-77°F)
  • do not use if pouch is opened
  • see bottom of this panel 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

SPL UNCLASSIFIED SECTION

Dist By:
Medtech Products, Inc. Tarrytown, NY 10591

Product Repackaged and Distributed
with permission of manufacturer by:
Select Corporation Carrollton, TX 75007

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1
Pharmacist
Recommended
BRAND

DIMENHYDRINATE
TABLETS / ANTIEMETIC

Dramamine®

motion sickness

CHEWABLE

Dual Action:

Prevents & Relieves Nausea,
Dizziness and Vomiting

TO OPEN
PUSH IN TAB AND PULL OUT

25 Packets of 2 Orange Flavor Tablets
(50 mg each)

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Packet Carton
PRINCIPAL DISPLAY PANEL - 50 mg Tablet Packet Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198603dimenhyDRINATE 50 MG Oral TabletPSN1
201716Dramamine 50 MG Oral TabletPSN1
201716dimenhydrinate 50 MG Oral Tablet [Dramamine]SBD1
198603dimenhydrinate 50 MG Oral TabletSCD1
201716Dramamine 50 MG Oral TabletSY1

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-962-042024-01-30C16284748780-11030e365-1905-111a-e063-dadaa90a10e2Dramamine ®
52904-962-252024-01-30C16284748780-11030e365-1905-111a-e063-dadaa90a10e2Dramamine ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-962-04Dramamine2 in 1 POUCHTABLET21
52904-962-04Dramamine1 in 1 BLISTER PACKTABLET11
52904-962-25Dramamine25 in 1 CARTONTABLET251
52904-962-25Dramamine2 in 1 POUCHTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-962DRAMAMINE (DIMENHYDRINATE) TABLET [SELECT CORPORATION]1Legacy NDC, 4 package rows20220415_ec76597c-eb6a-4025-9d64-fb79c2daca51.zip

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
52904-96252904-962-04, 52904-962-25
63029-901

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
9bca7cdc-8f19-4c96-acfa-6b332faaf7c0ec76597c-eb6a-4025-9d64-fb79c2daca512022-04-14WarningsExact identifier
spl id: 9bca7cdc-8f19-4c96-acfa-6b332faaf7c0
spl set id: ec76597c-eb6a-4025-9d64-fb79c2daca51

Reported adverse events (FAERS/openFDA)#

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