FDA.reportPublic FDA data

Mucinex Fast-Max

Manufacturer
Reckitt Benckiser LLC
Effective date
2017-05-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:16:04

Label at a glance#

ProductMucinex Fast-Max Day Severe Cold and Night Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure11 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: cough minor aches and pains headache nasal congestion sore throat runny nose and sneezing (NIGHT only) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only) controls cough to help you get to sleep (NIGHT only) 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 older: take 2 liquid gels every 4 hours children under 12 years of age: do not use

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each liquid gel)
Mucinex FAST-MAX DAY Severe Cold		Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each liquid gel)
Mucinex FAST-MAX NIGHT Cold & Flu		Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • minor aches and pains
    • headache
    • nasal congestion
    • sore throat
    • runny nose and sneezing (NIGHT only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
  • controls cough to help you get to sleep (NIGHT only)
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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 older: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients (DAY only)

INACTIVE INGREDIENT SECTION

FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol, titanium dioxide, water

Inactive ingredients (NIGHT only)

INACTIVE INGREDIENT SECTION

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol, titanium dioxide, water

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 China

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-594-48

48 LIQUID GELS

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH*

Mucinex®
FAST-MAX®

DAY
SEVERE COLD

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

  • Relieves Aches, Fever & Sore Throat
  • Controls Cough
  • Relieves Nasal & Chest Congestion
  • Thins & Loosens Mucus

32
LIQUID GELS
(Liquid Filled
Capsules)

48TOTAL
AGES 12+

NIGHT
COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Doxylamine succinate - Antihistamine
Phenylephrine HCl - Nasal Decongestant

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

16
LIQUID GELS
(Liquid Filled
Capsules)

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-594-482023-09-07C16284748780-19d75b9d0-55f0-f424-e053-dadaa90a57ceMucinex® Fast-Max ® Day Severe Cold & Night Cold and Flu
63824-594-482020-01-31C16284748780-19d75b9d0-55f0-f424-e053-dadaa90a57ceMucinex® Fast-Max ® Day Severe Cold & Night Cold and Flu

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-594-24EA - Each63824-5942780c8e3-eec2-4c80-aa05-a05b27cd50f412015-08-04

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
63824-59463824-594-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT

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
017e83d0-1425-8648-e063-6294a90a00c9561d37f1-4432-49e6-8ab6-a8a4ebb539c72023-07-27WarningsExact identifier
spl set id: 561d37f1-4432-49e6-8ab6-a8a4ebb539c7

Reported adverse events (FAERS/openFDA)#

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