FDA.reportPublic FDA data

Dramamine Less Drowsy Meclizine Hydrochloride

Manufacturer
JC World Bell Wholesale Co., Inc.
Effective date
2025-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:24

Label at a glance#

ProductDramamine Less Drowsy Meclizine Hydrochloride
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure8 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#

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

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 tranquilzers.

When using this product

OTC - WHEN USING SECTION

  • drawsiness 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

SPL UNCLASSIFIED SECTION

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

1-800-382-7219Dramamine.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label3Outer Label3Inner Label 3Inner Label 3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995726Dramamine Less Drowsy 25 MG Oral TabletPSN1
995666meclizine HCl 25 MG Oral TabletPSN1
995726meclizine hydrochloride 25 MG Oral Tablet [Dramamine Less Drowsy]SBD1
995666meclizine hydrochloride 25 MG Oral TabletSCD1
995726Dramamine II 25 MG Oral TabletSY1
995726Dramamine Less Drowsy 25 MG Oral TabletSY1

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
50269-526-00Dramamine Less Drowsy Meclizine Hydrochloride2 in 1 BOXTABLET21
50269-526-00Dramamine Less Drowsy Meclizine Hydrochloride20 in 1 PACKETTABLET201

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
50269-52650269-526-00
63029-903

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
ANHYDROUS LACTOSE3SY5LH9PMKIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDEMedtech Products Inc.fa6a0969-7427-4b87-bc04-a2792665c2182026-09-04WarningsExact identifier
ndc (product): 63029-903
3de899a1-3871-eeba-e063-6394a90a4984113b2504-a0e9-4fa8-bdcf-31792fbd359c2025-09-03WarningsExact identifier
spl id: 3de899a1-3871-eeba-e063-6394a90a4984
spl set id: 113b2504-a0e9-4fa8-bdcf-31792fbd359c

Reported adverse events (FAERS/openFDA)#

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