FDA.reportPublic FDA data

Mucinex® Fast-Max

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-19
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:58:03

Label at a glance#

ProductMucinex Fast-Max Severe Congestion and Cough
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 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 nasal congestion due to a cold

Dosage and administration

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

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

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purposes
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant

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
    • nasal congestion due to a cold

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

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

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough 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.

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 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 information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aluminum, croscarmellose sodium, FD&C blue no. 2

aluminum lake, FD&C red no. 40 aluminum lake,
methacrylic acid and ethyl acrylate copolymer,
mica, microcrystalline cellulose, polyethylene glycol,
polysorbate 80, polyvinyl alcohol, povidone, sodium
bicarbonate, 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

NDC 63824-157-20

full carton labelfull carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2173726dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral TabletPSN13
2173726dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral TabletSCD13

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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-faqs72854-157 full carton label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-157-20Mucinex Fast-MaxSevere Congestion and Cough10 in 1 BLISTER PACKTABLET, COATED1013
72854-157-20Mucinex Fast-MaxSevere Congestion and Cough2 in 1 CARTONTABLET, COATED213

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-15772854-157-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERNX76LV5T8JIACT
GUAIFENESIN495W7451VQACTIB
FD&C RED NO. 40WZB9127XOAIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
ALUMINUMCPD4NFA903IACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE K30U725QWY32XIACT
SODIUM BICARBONATE8MDF5V39QOIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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 Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC3270f369-7a40-186d-e063-6394a90a85262026-05-19WarningsExact identifier
ndc (package): 72854-157-20
ndc (product): 72854-157
ndc11 (package): 72854015720
spl id: 522db6ef-3021-ecbc-e063-6394a90aae0d
spl set id: 3270f369-7a40-186d-e063-6394a90a8526

Reported adverse events (FAERS/openFDA)#

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