Cardinal Health Mucus Relief D Drug Facts

Set ID
12971fb2-2314-4443-bf70-b7eb5859b148
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-03-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:02

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each extended-release bi-layer tablet)

Guaifenesin 1200 mg Pseudoephedrine HCl 120 mg

Purposes

Expectorant Nasal Decongestant

Uses

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure

Warnings

Warnings

Directions And Dosage

Directions

• do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for timing of meals • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours • children under 12 years of age: do not use

Other Label Information

Inactive ingredients

carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

LEADER ™ Maximum Strength Mucus Relief D Guaifenesin, 1200 mg Pseudoephedrine Hydrochloride, 120 mg Extended-Release Bi-Layer Tablets Expectorant | Nasal Decongestant 12-Hour Clears Nasal, Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release Actual Size COMPARE TO MAXIMUM STRENGTH MUCINEX ® D active ingredients 24 EXTENDED-RELEASE BI-LAYER TABLETS 100% Money Back Guarantee

Products

NDC Codes

Ingredients

NameUNIIKind
GUAIFENESIN495W7451VQACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT

Complete SPL Sections

Active ingredients (in each extended-release bi-layer tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 1200 mg Pseudoephedrine HCl 120 mg

Purposes

OTC - PURPOSE SECTION

Expectorant Nasal Decongestant

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 • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for timing of meals • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours • children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

• do not use if printed blister unit is broken or torn • store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 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 ™ Maximum Strength Mucus Relief D Guaifenesin, 1200 mg Pseudoephedrine Hydrochloride, 120 mg Extended-Release Bi-Layer Tablets Expectorant | Nasal Decongestant 12-Hour Clears Nasal, Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release Actual Size COMPARE TO MAXIMUM STRENGTH MUCINEX ® D active ingredients 24 EXTENDED-RELEASE BI-LAYER TABLETS 100% Money Back Guarantee

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc34G62E9C1.jpg2025-03-15
otcc2efc939-9978-426f-b112-8ef347b3fa20.xml2025-03-15