FDA.reportPublic FDA data

Dramamine

Manufacturer
Select Consumer Group
Effective date
2026-10-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-20 03:03:04

Label at a glance#

ProductDramamine Less Drowsy
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Meclizine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Antiemetic

Use

INDICATIONS & USAGE SECTION

Usefor prevention and treatment of these symptoms associated with
motion sickness:

  • nausea
  • vomiting
  • dizziness

Warnings

WARNINGS SECTION

Warnings
Do not give to children under 12 years of age unless directed by a doctor.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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

Ask a doctor or pharmacist before use if you are takingsedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

When using this product

  • 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

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

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

Other information

SPL UNCLASSIFIED SECTION

Other information
store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Questions?1-800-382-7219 Dramamine.com

Dramamnie ®Less Drowsy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DramamineDramamine#1

Pharmacist

Recommended

BRAND

MECLIZINE HYDROCHLORIDE

TABLETS /ANTIEMETIC

Dramamine ®

notion sickness

LESS DROWSY

Dual Action:

Prevents & Relieves Nausea,

Dizziness and Vomiting

UP TO

24

HOURS

2 Tablets

(25 MG EACH)

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708219225GTIN-13: 0655708219225
EAN-13: 0655708219225
GTIN-12: 655708219225
UPC-A: 655708219225
GTIN storage (14 digits): 00655708219225		2521922317 - Dramamine Less Drowsy - 1922-2.jpg

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
85237-192285237-1922-0, 85237-1922-1, 85237-1922-2, 85237-1922-4
66715-9734

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
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT

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 Less Drowsy, Lil Drug StoreMECLAZINE HYDROCHLORIDE TABLETLil' Drug Store Products, Inc.275b3377-9280-c12c-e063-6294a90a54212024-11-20WarningsExact identifier
ndc (product): 66715-9734

Reported adverse events (FAERS/openFDA)#

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