Mucinex® Fast-Max

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:58:07

Label at a glance#

ProductMucinex Fast-Max Cold, Flu and Sore Throat
Active ingredientACETAMINOPHEN, GUAIFENESIN
Label structure12 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 caplets in any 24-hour period adults and children 12 years of age and older: take 2 caplets every 4 hours children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each caplet)

Acetaminophen 325 mg
Guaifenesin 200mg

OTC - PURPOSE SECTION

Active ingredients Purposes
(in each caplet)

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 older:
    take 2 caplets every 4 hours
  • children under 12 years of age: do not use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


Keep out of reach of children.


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.

Warnings

WARNINGS SECTION

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.

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

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full carton labelfull carton label

back labelback label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
602617acetaminophen 325 MG / guaiFENesin 200 MG Oral TabletPSN2
602617acetaminophen 325 MG / guaifenesin 200 MG Oral TabletSCD2
602617APAP 325 MG / guaifenesin 200 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.mucinex.com/pages/product-faqs72854-162 front 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
72854-162-20Mucinex Fast-Max Cold, Flu and Sore Throat10 in 1 BLISTER PACKTABLET102
72854-162-20Mucinex Fast-Max Cold, Flu and Sore Throat2 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
72854-16272854-162-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-04-30weekly-update2026-06-03 18:02:30

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, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC50b140ad-aba2-ce6b-e063-6294a90ae2f82026-05-20WarningsExact identifier
ndc (package): 72854-162-20
ndc (product): 72854-162
ndc11 (package): 72854016220
spl id: 5242a71b-83b2-5e9f-e063-6394a90a5b4d
spl set id: 50b140ad-aba2-ce6b-e063-6294a90ae2f8

Reported adverse events (FAERS/openFDA)#

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