FDA.reportPublic FDA data

Dramamine Chewable Dimenhydrinate

Manufacturer
JC World Bell Wholesale Co., Inc.
Effective date
2025-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:28

Label at a glance#

ProductDramamine Chewable Dimenhydrinate
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 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 ½ to 1 chewable tablet every 6-8 hours do not give more than 3 chewable tab...

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 givetochildren under 12 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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

Other information

OTHER SAFETY INFORMATION

  • Phenylketonurics: contains phenylalanine 0.84 mg per tablet
  • store at room temperature 20-25ºC (68-77ºF)
  • see side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous-citric-acid, aspartame, FD&C yellow no. 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions?

OTC - QUESTIONS SECTION

1-800-382-7219 Dramamine.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309913dimenhyDRINATE 50 MG Chewable TabletPSN1
602223Dramamine 50 MG Chewable TabletPSN1
602223dimenhydrinate 50 MG Chewable Tablet [Dramamine]SBD1
309913dimenhydrinate 50 MG Chewable TabletSCD1
602223Dramamine 50 MG Chewable TabletSY1

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
50269-525-00Dramamine Chewable Dimenhydrinate2 in 1 BOXTABLET, CHEWABLE21
50269-525-00Dramamine Chewable Dimenhydrinate20 in 1 PACKETTABLET, CHEWABLE201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-902-01EA - Each63029-90271490ff9-52be-463f-b4e6-50e6aacae5a712022-06-06

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
50269-52550269-525-00
63029-902

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASPARTAMEZ0H242BBR1IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SORBITOL506T60A25RIACT
DIMENHYDRINATEJB937PER5CACTIB

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 OrangeDIMENHYDRINATEMedtech Products Inc.76166156-bce1-492f-833e-6bbd07859c3f2026-09-17WarningsExact identifier
ndc (product): 63029-902
3de87801-a99e-cd57-e063-6394a90aca057a43a0bb-6b0c-440a-9216-9e2eba28a06d2025-09-03WarningsExact identifier
spl id: 3de87801-a99e-cd57-e063-6394a90aca05
spl set id: 7a43a0bb-6b0c-440a-9216-9e2eba28a06d

Reported adverse events (FAERS/openFDA)#

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