Mucinex® Cold & Flu ®

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:57:24

Label at a glance#

ProductMucinex Cold and Flu
Active ingredientACETAMINOPHEN, GUAIFENESIN
Label structure11 sections

Indications and uses

Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily reduces fever

Dosage and administration

■ do not take more than directed (see Overdose warning) ■ do not take more than 12 liquid gels in any 24-hour period ■ adults and children 12 years of age and over: take 2 liquid gels every 4 hours ■ children under 12 years of age: do not use ■ do not take more than directed (see Overdose warning) ■ do not take more than 12 liquid gels in any 24-hour period ■ adults and children 12 years of age and over: take 2 li...

Storage and handling

■ store at 20-25°C (68-77°F) ■ avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg.............Pain reliever/fever reducer
Guaifenesin 200 mg...............................................Expectorant

Uses

INDICATIONS & USAGE SECTION

Uses
■ temporarily relieves these common cold and flu symptoms:
■ minor aches and pains
■ headache ■ sore throat
■ helps loosen phlegm (mucus) and thin bronchial secretions
to rid the bronchial passageways of bothersome mucus
and make coughs more productive
■ temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
■ more than 12 liquid gels in 24 hours, which is the
maximum daily amount
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right
away.
Sore throat warning: If sore throat is severe, persists for
more than 2 days, is accompanied or followed by fever,
headache, rash, nausea, or vomiting, consult a doctor
promptly.

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not take more than directed (see Overdose warning)
■ do not take more than 12 liquid gels in any 24-hour period
■ adults and children 12 years of age and over: take
2 liquid gels every 4 hours
■ children under 12 years of age: do not use

RECENT MAJOR CHANGES SECTION

■ do not take more than directed (see Overdose warning)
■ do not take more than 12 liquid gels in any 24-hour period
■ adults and children 12 years of age and over: take
2 liquid gels every 4 hours
■ children under 12 years of age: do not use

Other Information

STORAGE AND HANDLING SECTION

■ store at 20-25°C (68-77°F)
■ avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 1, gelatin, glycerin, hypromellose, lecithin, light
mineral oil, polyethylene glycol, povidone, propylene glycol,
purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
©2021 RB Health

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fast Dissolving Liquid Gels!

NDC 72854-136-16

Mucinex®

COLD, FLU

Acetaminophen – Pain Reliever/Fever Reducer
Guaifenesin – Expectorant

✓Thins & Loosens Mucus
✓Relieves Sore Throat, Headache & Chest Congestion
✓Reduces Fever

16
LIQUID GELS
(Liquid Filled Capsules)

Actual Size

DAY TIME
FOR AGES 12+

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN4
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD4
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-136-16Mucinex Cold and Flu2 in 1 CARTONCAPSULE, LIQUID FILLED24
72854-136-16Mucinex Cold and Flu8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-136-16EA - Each72854-136d230c282-2d44-4e25-a141-38820912ca1512022-11-07

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-13672854-136-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Cold and FluACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLCe8bc4131-f7b0-926a-e053-2995a90a40ac2026-05-13WarningsExact identifier
ndc (package): 72854-136-16
ndc (product): 72854-136
ndc11 (package): 72854013616
spl id: 51b77e26-cde2-fd0e-e063-6394a90a46a0
spl set id: e8bc4131-f7b0-926a-e053-2995a90a40ac

Reported adverse events (FAERS/openFDA)#

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