DRAMAMINE

Manufacturer
Medtech Products Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:32:24

Label at a glance#

ProductDRAMAMINE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

■to prevent motion sickness take first dose ½ hour to 1 hour before activity that may result in nausea ■to treat motion sickness, take at first signs of symptoms ■ 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 (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

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 to

SPL UNCLASSIFIED SECTION

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

■to prevent motion sickness take first dose ½ hour to 1 hour before activity that may result in nausea

■to treat motion sickness, take at first signs of symptoms

■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 20°–25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor

Questions?

OTC - QUESTIONS SECTION

1-800-382-7219

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

All Day Less Drowsy Chewable Formula

Dramamine®

Meclizine HCl 25 mg /Motion Sickness Relief

12 Raspberry Cream Flavored Chewable Tablets (25mg EACH)

PRINCIPAL DISPLAY PANEL All Day Less Drowsy Chewable Formula Dramamine® Meclizine HCl 25 mg /Motion Sickness Relief 12 Raspberry Cream Flavored Chewable Tablets (25mg EACH)PRINCIPAL DISPLAY PANEL All Day Less Drowsy Chewable Formula Dramamine® Meclizine HCl 25 mg /Motion Sickness Relief 12 Raspberry Cream Flavored Chewable Tablets (25mg EACH)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2176732Dramamine Less Drowsy 25 MG Chewable TabletPSN2
995632meclizine HCl 25 MG Chewable TabletPSN2
2176732meclizine hydrochloride 25 MG Chewable Tablet [Dramamine Less Drowsy]SBD2
995632meclizine hydrochloride 25 MG Chewable TabletSCD2
2176732Dramamine Less Drowsy 25 MG Chewable TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MECLIZINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-906-12DRAMAMINE12 in 1 BLISTER PACKTABLET, CHEWABLE122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-906DRAMAMINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]2Current NDC, Legacy NDC, 1 package rows20241101_f8cf751a-9f19-4744-a350-cd22303435ee.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-90663029-906-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.f8cf751a-9f19-4744-a350-cd22303435ee2024-10-25WarningsExact identifier
ndc (package): 63029-906-12
ndc (product): 63029-906
ndc11 (package): 63029090612
spl id: 4c3ea8e1-d98a-45c3-9bce-b85dfe8044a4
spl set id: f8cf751a-9f19-4744-a350-cd22303435ee

Reported adverse events (FAERS/openFDA)#

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