Leader 44-403

Drug Facts

Composition & Product

Active Ingredients

Meclizine (25 mg)

Inactive Ingredients

Silicon Dioxide D&c Yellow No. 10 Aluminum Lake Lactose Monohydrate Magnesium Stearate Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: 44;403 Shape: round Color: yellow Size: 9 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-05-11

Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 25 mg

Uses

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

Directions

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

Do Not Use

for children under 12 years of age unless directed by a doctor.

Other Information

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

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

Questions Or Comments?

1-800-426-9391

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

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Medtech Products Inc., owner of the

registered trademark Dramamine® Less Drowsy.

50844 ORG042340327

©2023 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO,

ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of

Cardinal Health. All other marks are the property of their respective owners.

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

100%

Money Back

Guarantee

Return to place of purchase.

Leader 44-403A

When Using This Product

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,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Meclizine HCl 25 mg

Ask A Doctor Before Use If You Have

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

taking sedatives or tranquilizers.

Structured Label Content

Uses

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

Purpose

Antiemetic

Directions

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

Do Not Use (Do not use)

for children under 12 years of age unless directed by a doctor.

Other Information (Other information)

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 ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (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

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Medtech Products Inc., owner of the

registered trademark Dramamine® Less Drowsy.

50844 ORG042340327

©2023 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO,

ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of

Cardinal Health. All other marks are the property of their respective owners.

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

100%

Money Back

Guarantee

Return to place of purchase.

Leader 44-403A

When Using This Product (When using this product)

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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Meclizine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10 ALUMINUM LAKE", "unii": "CQ3XH3DET6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness", "Purpose": "Antiemetic", "Directions": "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", "Do not use": "for children under 12 years of age unless directed by a doctor.", "Other information": "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": "colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch", "Questions or comments?": "1-800-426-9391", "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 TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® Less Drowsy. 50844 ORG042340327 ©2023 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 100% Money Back Guarantee Return to place of purchase. Leader 44-403A", "When using this product": "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,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each tablet)": "Meclizine HCl 25 mg", "Ask a doctor before use if you have": "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": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information