Leader Tm

Leader Tm
SPL v3
SPL
SPL Set ID 1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2
Route
ORAL
Published
Effective Date 2024-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.5 mg)
Inactive Ingredients
Beta Carotene Corn Syrup Honey Soybean Lecithin Sucrose Water

Identifiers & Packaging

Pill Appearance
Shape: oval Color: yellow Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-10

Description

Menthol 2.5 mg

Purpose

Cough suppressant/oral anesthetic


Medication Information

Purpose

Cough suppressant/oral anesthetic

Description

Menthol 2.5 mg

Uses

temporarily relieves:

• cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

Section 42229-5

RESEALABLE BAG

Gluten and Dairy-Free

Soothing Drops

COMPARE TO HALLS ® active ingredient*

CLOSE BAG TO MAINTAIN FRESHNESS

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com   1-800-200-6313

Essential to Care™ Since 1979

Made in China

©2024 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.

*This product is not manufactured or distributed by Intercontinental Great Brands LLC., owner of the registered trademark HALLS ®.

Contains 10 calories per lozenge

CHOKING WARNING: SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4. CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.

All LEADER™ Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

Section 50565-1

Keep this and all drugs out of the reach of children.

Purposes

Cough suppressant/oral anesthetic

Warnings

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

• cough accompanied by excessive phlegm (mucus)

When using this productdo not exceed recommended dosage

Stop use and ask a doctor if

• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

• sore mouth symptoms do not improve in 7 days

• irritation, pain, or redness persists or worsens

Packaging

Directions

• adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor

• children under 2 years of age: ask a doctor

Drug Facts

Other Information

• store at room temperature.

• keep away from excessive heat or sunlight

do not use if primary bag seal has been torn or broken.

contains: SOY

Inactive Ingredients

beta carotene, corn syrup, honey, soy lecithin, sucrose, vanilla flavor, water.

Questions Or Comments?

Call +1-866-306-9136

You may also report concerns to this phone number

Monday to Friday, 9 AM -5 PM Eastern Time 

Active Ingredient (in Each Lozenge)

Menthol 2.5 mg


Structured Label Content

Uses

temporarily relieves:

• cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

Section 42229-5 (42229-5)

RESEALABLE BAG

Gluten and Dairy-Free

Soothing Drops

COMPARE TO HALLS ® active ingredient*

CLOSE BAG TO MAINTAIN FRESHNESS

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com   1-800-200-6313

Essential to Care™ Since 1979

Made in China

©2024 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.

*This product is not manufactured or distributed by Intercontinental Great Brands LLC., owner of the registered trademark HALLS ®.

Contains 10 calories per lozenge

CHOKING WARNING: SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4. CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.

All LEADER™ Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.

Purposes

Cough suppressant/oral anesthetic

Warnings

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

• cough accompanied by excessive phlegm (mucus)

When using this productdo not exceed recommended dosage

Stop use and ask a doctor if

• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

• sore mouth symptoms do not improve in 7 days

• irritation, pain, or redness persists or worsens

Packaging

Directions

• adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor

• children under 2 years of age: ask a doctor

Drug Facts

Other Information (Other information)

• store at room temperature.

• keep away from excessive heat or sunlight

do not use if primary bag seal has been torn or broken.

contains: SOY

Inactive Ingredients (Inactive ingredients)

beta carotene, corn syrup, honey, soy lecithin, sucrose, vanilla flavor, water.

Questions Or Comments? (Questions or comments?)

Call +1-866-306-9136

You may also report concerns to this phone number

Monday to Friday, 9 AM -5 PM Eastern Time 

Active Ingredient (in Each Lozenge) (Active ingredient (in each lozenge))

Menthol 2.5 mg


Advanced Ingredient Data


Raw Label Data

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