Leader Mucus Relief - Cardinal Health 110, LLC. dba Leader

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:53:04

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Warnings

Directions And Dosage

Directions

• do not crush, chew, or break extended-release tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. • children under 12 years of age: do not use

Other Label Information

Inactive ingredients

carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

LEADER ™ Mucus Relief Guaifenesin, 600 mg Extended-Release Tablets Expectorant 12-Hour Relieves Chest Congestion Thins and Loosens Mucus Immediate and Extended Release Actual Size COMPARE TO MUCINEX ® active ingredient 100% Money Back Guarantee 20 EXTENDED-RELEASE TABLETS

Label Images

2X2C9E9C1
2X2C9E9C1

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 600 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• do not crush, chew, or break extended-release tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. • children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

• store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER ™ Mucus Relief Guaifenesin, 600 mg Extended-Release Tablets Expectorant 12-Hour Relieves Chest Congestion Thins and Loosens Mucus Immediate and Extended Release Actual Size COMPARE TO MUCINEX ® active ingredient 100% Money Back Guarantee 20 EXTENDED-RELEASE TABLETS

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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