FDA.reportPublic FDA data

DRAMAMINE - N

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 00:32:16

Label at a glance#

ProductDRAMAMINE - N
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

■ take first dose one hour before activity that may result in nausea ■ 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 use

OTC - DO NOT USE SECTION

for 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 one hour before activity that may result in nausea

■ 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

anhydrous lactose, corn starch, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions?

OTC - QUESTIONS SECTION

1-800-382-7219 Dramamine.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dramamine®-N

Meclizine Hydrochloride Tablets/Antiemetic

10 Tablets

PRINCIPAL DISPLAY PANEL Dramamine®-N Meclizine Hydrochloride Tablets/Antiemetic 10 TabletsPRINCIPAL DISPLAY PANEL Dramamine®-N Meclizine Hydrochloride Tablets/Antiemetic 10 Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2110527Dramamine Nausea Relief 25 MG Oral TabletPSN2
995666meclizine HCl 25 MG Oral TabletPSN2
2110527meclizine hydrochloride 25 MG Oral Tablet [Dramamine Nausea Relief]SBD2
995666meclizine hydrochloride 25 MG Oral TabletSCD2
2110527Dramamine Nausea Relief 25 MG Oral 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
63029-905-10DRAMAMINE - N5 in 1 BLISTER PACKTABLET52
63029-905-10DRAMAMINE - N2 in 1 BOXTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-905DRAMAMINE - N (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2Current NDC, Legacy NDC, 2 package rows20241101_7fec7791-c242-4e43-8184-32820e657afb.zip

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
63029-90563029-905-10

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
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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 - NMECLIZINE HYDROCHLORIDEMedtech Products Inc.7fec7791-c242-4e43-8184-32820e657afb2024-10-25WarningsExact identifier
ndc (package): 63029-905-10
ndc (product): 63029-905
ndc11 (package): 63029090510
spl id: 101152a8-cb8e-4f6f-b52a-6667b6343a24
spl set id: 7fec7791-c242-4e43-8184-32820e657afb

Reported adverse events (FAERS/openFDA)#

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