FDA.reportPublic FDA data

Mucinex Fast-Max

Manufacturer
Reckitt Benckiser LLC
Effective date
2016-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:21:23

Label at a glance#

ProductMucinex Fast-Max Severe Congestion and Cough Liquid Pouches
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
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 nasal congestion due to a cold temporarily helps you cough less

Dosage and administration

do not take more than 6 doses in any 24-hour period dose as follows or as directed by a doctor adults and children 12 years of age and older: one 20 mL single dose pouch every 4 hours children under 12 years of age: do not use

Storage and handling

each 20 mL contains: sodium 14 mg store between 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each pouch)Purposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

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
    • nasal congestion due to a cold
  • temporarily helps you cough less

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
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 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
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and older: one 20 mL single dose pouch every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 14 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

1 may contain this ingredient

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: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL - 20 mL Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
NDC 63824-546-44

Mucinex®
FAST-MAX®

SEVERE CONGESTION
& COUGH

LIQUID
POUCHES

Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

  • Controls Cough
  • Relieves Nasal
    & Chest Congestion
  • Thins & Loosens
    Mucus

4 0.68 FL OZ (20 mL)
SINGLE DOSE POUCHES
Total 2.71 FL OZ (80 mL)

product not to scale

PRINCIPAL DISPLAY PANEL - 20 mL Pouch Carton
PRINCIPAL DISPLAY PANEL - 20 mL Pouch Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-546-442023-09-07C16284748780-19d75b9d0-614e-f424-e053-dadaa90a57ceMucinex® Fast-Max ® Severe Congestion & Cough Liquid Pouches
63824-546-442020-01-31C16284748780-19d75b9d0-614e-f424-e053-dadaa90a57ceMucinex® Fast-Max ® Severe Congestion & Cough Liquid Pouches

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
63824-54663824-546-01, 63824-546-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
anhydrous citric acidXF417D3PSLIACT
edetate disodium7FLD91C86KIACT
FD&C Red No. 40WZB9127XOAIACT
glycerinPDC6A3C0OXIACT
propyl gallate8D4SNN7V92IACT
propylene glycol6DC9Q167V3IACT
sodium benzoateOJ245FE5EUIACT
sorbitol506T60A25RIACT
sucralose96K6UQ3ZD4IACT
trisodium citrate dihydrateB22547B95KIACT
water059QF0KO0RIACT
xanthan gumTTV12P4NEEIACT

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
017e362a-854f-3258-e063-6294a90ad8008f05e4f0-a455-4700-899f-8129c173df2f2023-07-27WarningsExact identifier
spl set id: 8f05e4f0-a455-4700-899f-8129c173df2f

Reported adverse events (FAERS/openFDA)#

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