FDA.reportPublic FDA data

Dramamine Chewable Orange - Meclizine - 63029-915

Manufacturer
Medtech Products Inc.
Effective date
2026-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:33:22

Label at a glance#

ProductDRAMAMINE CHEWABLE ORANGE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

take first dose 1/2 to 1 hour before starting activity adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Meclizine HCL 25 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

OTC - DO NOT USE SECTION

to children 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 if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

  • take first dose 1/2 to 1 hour before starting activity
  • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, ascorbic acid, butylated hydroxytoluene, corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 lake, lactose monohydrate, magnesium stearate, maltodextrin, natural orange flavor, natural pink lemonade flavor, saccharin sodium, silicon dioxide, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-382-7219

Dramamine.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dramamine®

MECLIZINE HYDROCHLORIDE | ANTIEMETIC | 25 MG
motion sickness
CHEWABLE
Dual Action:
Prevents & Relieves Nausea,
Dizziness and Vomiting
8 ORANGE-FLAVORED CHEWABLE TABLETS

PRINCIPAL DISPLAY PANEL Dramamine® MECLIZINE HYDROCHLORIDE | ANTIEMETIC | 25 MG motion sickness CHEWABLE Dual Action: Prevents & Relieves Nausea, Dizziness and Vomiting 8 ORANGE...PRINCIPAL DISPLAY PANEL Dramamine® MECLIZINE HYDROCHLORIDE | ANTIEMETIC | 25 MG motion sickness CHEWABLE Dual Action: Prevents & Relieves Nausea, Dizziness and Vomiting 8 ORANGE...

PRINCIPAL DISPLAY PANEL Dramamine® MECLIZINE HYDROCHLORIDE | ANTIEMETIC | 25 MG motion sickness CHEWABLE Dual Action: Prevents & Relieves Nausea, Dizziness and Vomiting 8 ORANGE...PRINCIPAL DISPLAY PANEL Dramamine® MECLIZINE HYDROCHLORIDE | ANTIEMETIC | 25 MG motion sickness CHEWABLE Dual Action: Prevents & Relieves Nausea, Dizziness and Vomiting 8 ORANGE...

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130831248000671GTIN-13: 0831248000671
EAN-13: 0831248000671
GTIN-12: 831248000671
UPC-A: 831248000671
GTIN storage (14 digits): 00831248000671		dramamine-chewable-orange---meclizine---63029-915-02.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-91563029-915-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRAMAMINE CHEWABLE ORANGEMECLIZINE HYDROCHLORIDEMedtech Products Inc.30387e63-278d-412a-bcad-7965c7c0aea72026-06-23WarningsExact identifier
ndc (package): 63029-915-08
ndc (product): 63029-915
ndc11 (package): 63029091508
spl id: d39b919b-5f95-4fea-bdf7-bc876be524d4
spl set id: 30387e63-278d-412a-bcad-7965c7c0aea7

Reported adverse events (FAERS/openFDA)#

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