Mucinex® Cold & Flu

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-10-16
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-20 03:03:39

Label at a glance#

ProductMucinex Cold and Flu
Active ingredientACETAMINOPHEN, GUAIFENESIN
Label structure14 sections

Indications and 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

Active ingredients (in each liquid gel)
Acetaminophen 325 mg

Guaifenesin 200 mg

OTC - PURPOSE SECTION

Purposes
Acetaminophen 325 mg.............Pain reliever/fever reducer

Guaifenesin 200 mg...............................................Expectorant

Uses

INDICATIONS & USAGE SECTION

■ 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.

Do not use
■
with any other drug containing acetaminophen (prescription
or nonprescription). If you are not sure whether a drug contains
acetaminophen, as a doctor or pharmacist.

Ask a doctor before use if you have
■
liver disease
■ persistent or chronic cough such as occurs with smoking,
asthma, chronic bronchitis, or emphysema
■ cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking
the blood thinning drug warfarin

When using this product do not use more than directed

Stop use and ask a doctor if
■ pain or cough gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
■ cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional
before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Overdose warning: Taking more than the recommended dose
(overdose) may cause liver damage. In case of overdose, get
medical help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well as for children
even if you do not notice any signs or symptoms.

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72854-136-16

LabelLabel

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-05-13full-release2026-06-01 01:57:24

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 set id: e8bc4131-f7b0-926a-e053-2995a90a40ac

Reported adverse events (FAERS/openFDA)#

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