FDA.reportPublic FDA data

Dramamine Chewable Orange

Manufacturer
Medtech Products Inc.
Effective date
2026-09-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-09-22 03:03:01

Label at a glance#

ProductDramamine Orange
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 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 tablet every 6-8 hours do not give more than 3 chewable tablets in 24 hours, ...

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 giveto

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

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 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 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 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 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 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 68-77ºF (20-25ºC)
  • do not use if carton is opened or if blister is broken or torn
  • see side 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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dimenhydrinate Tablets/Antiemetic
CHEWABLE FORMULA
Dramamine ®
MOTION SICKNESS RELIEF
DUAL ACTION
1. TREATS SYMPTOMS ON THE SPOT
2. PREVENTS NAUSEA, DIZZINESS & VOMITING
Convenient Chewable Tablets
8 ORANGE FLAVORED TABLETS (50 mg EACH)

PRINCIPAL DISPLAY PANEL Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine® MOTION SICKNESS RELIEF DUAL ACTION 1. TREATS SYMPTOMS ON THE SPOT 2. PREVENTS NAUSEA, DIZZI...PRINCIPAL DISPLAY PANEL Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine® MOTION SICKNESS RELIEF DUAL ACTION 1. TREATS SYMPTOMS ON THE SPOT 2. PREVENTS NAUSEA, DIZZI...

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dimenhydrinate Tablets/Antiemetic
CHEWABLE FORMULA
Dramamine ®
MOTION SICKNESS RELIEF
DUAL ACTION
1. TREATS SYMPTOMS ON THE SPOT
2. PREVENTS NAUSEA, DIZZINESS & VOMITING
Convenient Chewable Tablets
2 ORANGE FLAVORED TABLETS (50 mg EACH)

PRINCIPAL DISPLAY PANEL Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine® MOTION SICKNESS RELIEF DUAL ACTION 1. TREATS SYMPTOMS ON THE SPOT 2. PREVENTS NAUSEA, DIZZI...PRINCIPAL DISPLAY PANEL Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine® MOTION SICKNESS RELIEF DUAL ACTION 1. TREATS SYMPTOMS ON THE SPOT 2. PREVENTS NAUSEA, DIZZI...

DailyMed Product Concepts#

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

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMENHYDRINATEACTIVE INGREDIENTJB937PER5C3
CHLORTHEOPHYLLINEACTIVE MOIETYGE2UA340FM3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A83
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D3
SORBITOLINACTIVE INGREDIENT506T60A25R3

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-90263029-902-01, 63029-902-02, 63029-902-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMENHYDRINATEJB937PER5CACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASPARTAMEZ0H242BBR1IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ALUMINUM OXIDELMI26O6933IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-09-10full-release2026-06-01 01:13:16

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 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
4 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 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 OrangeDIMENHYDRINATEMedtech Products Inc.76166156-bce1-492f-833e-6bbd07859c3f2026-09-17WarningsExact identifier
ndc (package): 63029-902-04
ndc (package): 63029-902-01
ndc (package): 63029-902-02
ndc (product): 63029-902
ndc11 (package): 63029090204
ndc11 (package): 63029090201
ndc11 (package): 63029090202
spl id: 5bb5061c-c75c-0d41-e063-6294a90a2c59
spl set id: 76166156-bce1-492f-833e-6bbd07859c3f

Reported adverse events (FAERS/openFDA)#

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