Mucinex Fast-Max Cold & Flu

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:58:03

Label at a glance#

ProductMucinex Fast-Max Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 sections

Indications and uses

Uses ■ temporarily relieves these common cold and flu symptoms: ■ 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 ■ minor aches and pains ■ sore throat ■ headache ■ temporarily reduces fever

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg...Pain reliever/fever reducer
Dextromethorphan HBr 10 mg...Cough suppressant

Uses

INDICATIONS & USAGE SECTION

Uses
■ temporarily relieves these common cold and flu
symptoms:
■ 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
■ minor aches and pains
■ sore throat

■ headache
■ temporarily reduces fever

WARNINGS SECTION

Warnings
Liver warning: This product contains acetaminophen.


Severe liver damage may occur if you take:
■ more than 12 caplets in 24 hours, which is the
maximum daily amount for this product
■ 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,
ask a doctor or pharmacist.
■ 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
■ liver disease
■ persistent or chronic cough such as occurs with
smoking, asthma, 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

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

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

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

OTHER SAFETY INFORMATION

Other information
■ store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients
croscarmellose sodium, FD&C red no. 40 aluminum
lake, FD&C yellow no. 6 aluminum lake,
microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol, povidone, talc, titanium dioxide

OTC - QUESTIONS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Acetaminophen » Pain Reliever/Fever Reducer
Dextromethorphan HBr » Cough Suppressant

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back labelback label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletPSN2
2709673acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSCD2
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletSY2
2709673APAP 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.mucinex.com/pages/product-faqs72854-161 label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-161-02Mucinex Fast-Max Cold and Flu2 in 1 POUCHTABLET22
72854-161-04Mucinex Fast-Max Cold and Flu2 in 1 CARTONTABLET22
72854-161-04Mucinex Fast-Max Cold and Flu2 in 1 POUCHTABLET22
72854-161-10Mucinex Fast-Max Cold and Flu10 in 1 BLISTER PACKTABLET102
72854-161-10Mucinex Fast-Max Cold and Flu1 in 1 CARTONTABLET12
72854-161-20Mucinex Fast-Max Cold and Flu10 in 1 BLISTER PACKTABLET102
72854-161-20Mucinex Fast-Max Cold and Flu2 in 1 CARTONTABLET22

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-16172854-161-10, 72854-161-20, 72854-161-02, 72854-161-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC31ac6883-ffcd-39de-e063-6294a90a52dd2026-05-19WarningsExact identifier
ndc (package): 72854-161-10
ndc (package): 72854-161-04
ndc (package): 72854-161-02
ndc (package): 72854-161-20
ndc (product): 72854-161
ndc11 (package): 72854016120
ndc11 (package): 72854016110
ndc11 (package): 72854016102
ndc11 (package): 72854016104
spl id: 522dbf72-6c3c-de6a-e063-6394a90ac6ec
spl set id: 31ac6883-ffcd-39de-e063-6294a90a52dd

Reported adverse events (FAERS/openFDA)#

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