Mucinex® Cough & Chest Congestion

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 03:03:16

Label at a glance#

ProductMucinex Cough Chest Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

Indications and uses

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep

Dosage and administration

■ 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

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)

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg

OTC - PURPOSE SECTION

Purposes

Dextromethorphan HBr 10 mg................Cough suppressant
Guaifenesin 200 mg................................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
■ temporarily relieves:
■ cough due to minor throat and bronchial irritation as
may occur with the common cold or inhaled irritants
■ the intensity of coughing
■ the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

Do not use
■ if you are now taking a prescription monoamine oxidase
inhibitor (MAOI) (certain drugs for depression, psychiatric,
or emotional conditions, or Parkinson’s disease), or for
2 weeks after stopping the MAOI drug. If you do not know
if your prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product.

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

When using this product do not use more than directed

Stop use and ask a doctor if
■ cough lasts more than 7 days, comes back, or occurs with
fever, 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

In case of overdose, get medical help or contact a Poison
Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

D&C yellow no. 10, 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 72854-137-16

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix322196672854-137 Mucinex Cough Chest Congestion liquid gel_Page_1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-137-16EA - Each72854-1372c1009be-3158-4185-a745-1b82f4d90f8b12022-11-07

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-13772854-137-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-05-13full-release2026-06-01 01:57:25

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
51b8027e-7ca8-4dd4-e063-6294a90af406e9c32d81-cd9b-4ff2-e053-2995a90aa4992026-05-13WarningsExact identifier
spl set id: e9c32d81-cd9b-4ff2-e053-2995a90aa499

Reported adverse events (FAERS/openFDA)#

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