FDA.reportPublic FDA data

Mucinex Fast-Max Severe Congestion and Cough Clear and Cool

Manufacturer
RB Health (US) LLC
Effective date
2018-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:43:04

Label at a glance#

ProductMucinex Fast-Max Severe Congestion and Cough Clear and Cool and Mucinex Fast-Max Night Time Cold and Flu Clear and Cool
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 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 (DAY TIME only) temporarily relieves (DAY TIME only) : 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 temporarily relieves th...

Dosage and administration

do not take more than directed (see Overdose warning ) 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 older: 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 9 mg store between 20-25°C (68-77°F) dosing cup provided do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)
Mucinex FAST-MAX Severe Congestion & Cough CLEAR & COOL		Purposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)
Mucinex FAST-MAX NIGHT TIME Cold & Flu CLEAR & COOL		Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Diphenhydramine HCl 25 mgAntihistamine/cough suppressant
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 (DAY TIME only)
  • temporarily relieves (DAY TIME only):
    • 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
  • temporarily relieves these common cold and flu symptoms (NIGHT TIME only):
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
  • temporarily reduces fever (NIGHT TIME only)
  • controls cough to help you get to sleep (NIGHT TIME only)

Warnings

WARNINGS SECTION

Liver warning (NIGHT TIME only)

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses 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 (NIGHT TIME only)

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 (NIGHT TIME only)

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 (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (NIGHT TIME only)
  • with any other drug containing diphenhydramine, even one used on the skin (NIGHT TIME only)
  • 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

  • liver disease (NIGHT TIME only)
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (NIGHT TIME only)
  • breathing problems such as emphysema or chronic bronchitis (NIGHT TIME only)
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin (NIGHT TIME only)
  • taking sedatives or tranquilizers (NIGHT TIME only)

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children (NIGHT TIME only)
  • marked drowsiness may occur (NIGHT TIME only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME only)
  • avoid alcoholic drinks (NIGHT TIME only)
  • be careful when driving a motor vehicle or operating machinery (NIGHT TIME only)

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 (DAY TIME only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (NIGHT TIME only)
  • fever gets worse or lasts more than 3 days (NIGHT TIME only)
  • redness or swelling is present (NIGHT TIME only)
  • new symptoms occur (NIGHT TIME only)
  • 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 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 older: 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 9 mg
  • store between 20-25°C (68-77°F)
  • dosing cup provided
  • do not refrigerate

Inactive ingredients (Mucinex FAST-MAX Severe Congestion & Cough CLEAR & COOL)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C yellow no.10, edetate disodium, FD&C blue no.1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Inactive ingredients (Mucinex FAST-MAX NIGHT TIME Cold & Flu CLEAR & COOL)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C yellow no.10, edetate disodium, FD&C blue no.1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, 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: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-541-66

MAXIMUM STRENGTH

Mucinex®
FAST- MAX®

SEVERE CONGESTION
& COUGH

CLEAR & COOL ™

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

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

6 FL OZ (180mL)
FOR AGES 12+

NDC 63824-510-66

MAXIMUM STRENGTH*

Mucinex®
FAST- MAX®

NIGHT TIME
COLD & FLU

CLEAR & COOL ™

Acetaminophen – Pain Reliever/Fever Reducer
Diphenhydramine HCl - Antihistamine/Cough Suppressant
Phenylephrine HCl – Nasal Decongestant

✓ Relieves Aches, Fever & Sore Throat
✓ Controls Cough
✓ Relieves Nasal Congestion
✓ Relieves Runny Nose & Sneezing

6 FL OZ (180mL)
FOR AGES 12+

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-544-222023-10-02C16284748780-1ba0f9c33-4c6a-a910-e053-dadaa90a0b85Mucinex® Fast-Max ® Severe Congestion & Cough Clear & Cool ™ and Mucinex® Fast-Max ® Night Time Cold & Flu Clear & Cool ™
63824-544-222021-01-29C16284748780-1ba0f9c33-4c6a-a910-e053-dadaa90a0b85Mucinex® Fast-Max ® Severe Congestion & Cough Clear & Cool ™ and Mucinex® Fast-Max ® Night Time Cold & Flu Clear & Cool ™

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-544-22ML - Milliliter63824-544a0b29a72-3221-4191-a4d8-4e69acfe86ad12017-08-11
63824-541-66ML - Milliliter63824-5415e0b0836-4d87-463e-b7c6-38ee5d09ba4d12017-09-11

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-54463824-544-22
63824-54163824-541-66
63824-51063824-510-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
anhydrous citric acidXF417D3PSLIACT
D&C yellow no. 1035SW5USQ3GIACT
edetate disodium7FLD91C86KIACT
Fd&C Blue No. 1H3R47K3TBDIACT
glycerinPDC6A3C0OXIACT
propyl gallate8D4SNN7V92IACT
propylene glycol6DC9Q167V3IACT
sodium benzoateOJ245FE5EUIACT
sodium citrate, unspecified form1Q73Q2JULRIACT
sorbitol506T60A25RIACT
sucralose96K6UQ3ZD4IACT
water059QF0KO0RIACT
xanthan gumTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
anhydrous citric acidXF417D3PSLIACT
D&C yellow no. 1035SW5USQ3GIACT
edetate disodium7FLD91C86KIACT
Fd&C Blue No. 1H3R47K3TBDIACT
glycerinPDC6A3C0OXIACT
propyl gallate8D4SNN7V92IACT
propylene glycol6DC9Q167V3IACT
sodium benzoateOJ245FE5EUIACT
sodium citrate, unspecified form1Q73Q2JULRIACT
sorbitol506T60A25RIACT
sucralose96K6UQ3ZD4IACT
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
06c22e1f-80d6-8127-e063-6294a90a24812723db81-b382-4ee1-9e33-bb7c84e598af2023-10-02WarningsExact identifier
spl set id: 2723db81-b382-4ee1-9e33-bb7c84e598af

Reported adverse events (FAERS/openFDA)#

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