Leader 44-403

Manufacturer: Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
Effective date: 2026-06-16
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: daily-update
Hydrated at: 2026-07-15 00:32:47

Label at a glance#

ProductMotion Sickness Relief

Active ingredientMECLIZINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Dosage and administration

do not take more than directed take first dose ½ 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

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from heat and humidity see end flap for expiration date and lot number

Contacts and useful links#

PhoneLabel contact1-800-426-9391

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

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

difficulty in urination due to enlargement of the prostate gland
glaucoma
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
take first dose ½ 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

STORAGE AND HANDLING SECTION

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from heat and humidity
see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0097-1

Less Drowsy Formula
Motion Sickness Relief
Meclizine HCI, 25 mg | Antiemetic

Helps Prevent Nausea,
Vomiting and Dizziness
Due to Motion Sickness
For Up to 24 Hours
Ages 12 Years and Over

COMPARE TO
DRAMAMINE®
LESS DROWSY
active ingredient*

100% Money Back Guarantee

32 TABLETS

Actual Size

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0096295140996	GTIN-13: 0096295140996 EAN-13: 0096295140996 GTIN-12: 096295140996 UPC-A: 096295140996 GTIN storage (14 digits): 00096295140996	leader-44-403-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0097-1	EA - Each	70000-0097	4de46378-9cad-4928-91fd-29bc082f6a86	1	2021-11-09

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Motion Sickness Relief
Meclizine HCl
MECLIZINE HYDROCHLORIDE
MECLIZINE
SILICON DIOXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70000-0097	70000-0097-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
D&C YELLOW NO. 10 ALUMINUM LAKE	CQ3XH3DET6	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
8	2025-06-07	full-release	2026-06-01 01:02:32

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Motion Sickness Relief	MECLIZINE HCL	Cardinal Health 110, LLC. DBA Leader	69099658-a584-49a9-8a95-de258a697c4f	2026-06-16	Warnings	Exact identifier ndc (package): 70000-0097-1 ndc (product): 70000-0097 ndc11 (package): 70000009701 spl id: 2fabb184-4c5a-4cad-8ca0-ef92013f5f5a spl set id: 69099658-a584-49a9-8a95-de258a697c4f

Reported adverse events (FAERS/openFDA)#

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