FDA.reportPublic FDA data

Mucinex® Fast-Max

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:57:12

Label at a glance#

ProductMucinex Fast-Max Chest Congestion Honey and Berry Flavor
Active ingredientGUAIFENESIN
Label structure11 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

Dosage and administration

do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

Storage and handling

each 20 mL contains: sodium 12 mg store at 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 12 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, flavors, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

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 - 180 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
NDC 63824-537-66

Mucinex®
FAST-MAX ®

CHEST CONGESTION

Honey
& Berry Flavor

Guaifenesin – Expectorant

  • Relieves Chest Congestion
  • Thins & Loosens Mucus
  • 4 Hour Dosing

6 FL OZ (180 mL)
FOR AGES 12+

010720
3132639

Principal Display Panel - 180 mL Bottle Label
Principal Display Panel - 180 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN5
669126Mucinex 100 MG in 5 mL Oral SolutionPSN5
669126guaifenesin 20 MG/ML Oral Solution [Mucinex]SBD5
310604guaifenesin 20 MG/ML Oral SolutionSCD5
669126Children's Mucinex 20 MG/ML Oral SolutionSY5
310604guaifenesin 100 MG per 5 ML Oral SolutionSY5
310604guaifenesin 100 MG per 5 ML Oral SyrupSY5
310604guaifenesin 200 MG per 10 ML Oral SolutionSY5
310604guaifenesin 300 MG per 15 ML Oral SolutionSY5
310604guaifenesin 400 MG per 20 ML Oral SolutionSY5
669126Mucinex 100 MG per 5 ML Oral SolutionSY5
669126Mucinex 20 MG/ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-537-66Mucinex Fast-Max Chest Congestion Honey and Berry Flavor180 mL in 1 BOTTLESOLUTION1805

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-53763824-537-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
GUAIFENESIN495W7451VQACTIB

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 Chest Congestion Honey and Berry FlavorGUAIFENESINReckitt Benckiser LLC8ec74cf2-88f5-40be-87e2-b756ab8417542026-05-13WarningsExact identifier
ndc (package): 63824-537-66
ndc (product): 63824-537
ndc11 (package): 63824053766
spl id: 51b44481-a7b9-8a46-e063-6294a90aefda
spl set id: 8ec74cf2-88f5-40be-87e2-b756ab841754

Reported adverse events (FAERS/openFDA)#

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