FDA.reportPublic FDA data

Mucinex

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:58:04

Label at a glance#

ProductMucinex Fast-Max Cold and Flu Maximum Strength
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and 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

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

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

OTC - PURPOSE SECTION

Active ingredients (in each liquid gel)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (precription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a precription 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 precription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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.

Overdose warning

SPL UNCLASSIFIED SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red no. 40, FD&C yellow
no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol,
lecithin (sunflower), light mineral oil, mannitol, polyethylene
glycol 400, povidone, propylene glycol, purified water,
1,4-sorbitan, sorbitol, 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 - 16 Capsule Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fast Dissolving Liquid Gels!

NDC 72854-171

MAXIMUM STRENGTH

MUCINEX®

FAST-MAX ®

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

LIQUID GELS

(Liquid Filled Capsules)

Actual Size

FOR AGES 12 +

carton labelcarton label

back labelback label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsulePSN5
1867684acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral CapsuleSCD5
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsuleSY5
1867684APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral CapsuleSY5

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
BarcodeEAN-130363824999005GTIN-13: 0363824999005
EAN-13: 0363824999005
GTIN-12: 363824999005
UPC-A: 363824999005
GTIN storage (14 digits): 00363824999005		72854-171 label front.jpg
QR code linkQR Codewww.mucinex.com/pages/product-faqs72854-171 label front.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
72854-171-08Mucinex Fast-Max Cold and FluMaximum Strength1 in 1 CARTONCAPSULE, LIQUID FILLED15
72854-171-08Mucinex Fast-Max Cold and FluMaximum Strength8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED85
72854-171-10Mucinex Fast-Max Cold and FluMaximum Strength1 in 1 CARTONCAPSULE, LIQUID FILLED15
72854-171-10Mucinex Fast-Max Cold and FluMaximum Strength10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105
72854-171-16Mucinex Fast-Max Cold and FluMaximum Strength8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED85
72854-171-16Mucinex Fast-Max Cold and FluMaximum Strength2 in 1 CARTONCAPSULE, LIQUID FILLED25

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-17172854-171-16, 72854-171-08, 72854-171-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ISOPROPYL ALCOHOLND2M416302IACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
1,4-SORBITANAV0YTZ4E6JIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
MANNITOL3OWL53L36AIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
ndc (package): 72854-171-08
ndc11 (package): 72854017108
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
ndc (package): 72854-171-10
ndc (package): 72854-171-08
ndc (package): 72854-171-16
ndc (product): 72854-171
ndc11 (package): 72854017110
ndc11 (package): 72854017108
ndc11 (package): 72854017116
spl id: 522dd821-a0c9-263b-e063-6294a90a1e3e
spl set id: 36b07e49-c72c-45e5-e063-6394a90a804a

Reported adverse events (FAERS/openFDA)#

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