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 01:57:08

Label at a glance#

ProductMucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, GUAIFENESIN
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 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 temporarily relieves these common cold and flu symptoms: cough minor aches...

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 do not take more than directed (see Overdose warning ) do not take more than 4 doses in any 24-hour period mea...

Storage and handling

each 20 mL contains: sodium 12 mg (Fast-Max DM Max only) and sodium 16 mg (Nightshift Cold & Flu only) store at 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 20 mL)
MUCINEX FAST-MAX DM MAX 		Purposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Active ingredients (in each 20 mL)
MUCINEX NIGHTSHIFT COLD & FLU 		Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Triprolidine HCl 2.5 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

MUCINEX FAST-MAX DM MAX

SPL UNCLASSIFIED 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

MUCINEX NIGHTSHIFT COLD & FLU

SPL UNCLASSIFIED SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings

WARNINGS SECTION

Liver warning (Nightshift Cold & Flu only)

SPL UNCLASSIFIED SECTION

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

  • more than 4000 mg 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 (Nightshift Cold & Flu 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 (Nightshift Cold & Flu 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. (Nightshift Cold & Flu 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 (Nightshift Cold & Flu only)
  • glaucoma (Nightshift Cold & Flu only)
  • trouble urinating due to an enlarged prostate gland (Nightshift Cold & Flu only)
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Cold & Flu 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 (Nightshift Cold & Flu only)
  • taking sedatives or tranquilizers (Nightshift Cold & Flu only)

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough gets worse or lasts more than 7 days (Nightshift Cold & Flu only)
  • fever gets worse or lasts more than 3 days (Nightshift Cold & Flu only)
  • redness or swelling is present (Nightshift Cold & Flu only)
  • new symptoms occur (Nightshift Cold & Flu only)
  • cough comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Cold & Flu only)
  • 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. (Fast-Max DM Max only)

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.

Overdose warning (Nightshift Cold & Flu only)

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. 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

MUCINEX FAST-MAX DM MAX

SPL UNCLASSIFIED 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

MUCINEX NIGHTSHIFT COLD & FLU

SPL UNCLASSIFIED SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 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 (Fast-Max DM Max only) and sodium 16 mg (Nightshift Cold & Flu only)
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients (MUCINEX FAST-MAX DM MAX)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum

1 may contain this ingredient

Inactive ingredients (MUCINEX NIGHTSHIFT COLD & FLU)

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, 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: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY & NIGHT
COUGH & COLD RELIEF

MAXIMUM STRENGTH
NDC 63824-118-66

Mucinex®
FAST-MAX ®

DM MAX

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant

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

Mucinex®
NIGHTSHIFT

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Triprolidine HCl – Antihistamine

NIGHTTIME
RELIEF FOR A BETTER
MORNING

✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING

FOR
AGES 12+

TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL)

FOR
AGES 12+

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287760{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } PackGPCK5
22877601 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) PackPSN5
2173667acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN5
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN5
2173667acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD5
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD5
22877601 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) PackSY5
2173667acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY5
2173667APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY5
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY5
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-118-662022-11-15C16284748780-1e4f33bdf-ad68-d8a0-e053-dadaa90a6e4eMucinex® Fast-Max ® DM Max and Mucinex® Nightshift Cold & Flu
63824-118-662022-07-29C16284748780-1e4f33bdf-ad68-d8a0-e053-dadaa90a6e4eMucinex® Fast-Max ® DM Max and Mucinex® Nightshift Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-019-66Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu180 mL in 1 BOTTLESOLUTION180 mL400 mg in 20mL5
63824-118-66Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu1 in 1 CARTONKIT15
63824-503-66Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu180 mL in 1 BOTTLESOLUTION180 mL650 mg in 20mL5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-118-66ML - Milliliter63824-118f4d47e64-7554-4c31-b88d-9eff96efe0c812022-07-06
63824-503-64ML - Milliliter63824-50395df1dbf-b97f-4d7a-8760-05dd8c14c0b112020-05-08
63824-503-66ML - Milliliter63824-503aa3fa020-f760-46c0-baf7-4ebadc39468712020-06-05
63824-503-69ML - Milliliter63824-503241bb60f-58eb-4913-a556-1081ee4c157012020-09-14
63824-019-66ML - Milliliter63824-019de56a7cd-8891-4cd0-ae71-eaa5dcedbeae12014-10-03

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-11863824-118-66
63824-50363824-503-66
63824-01963824-019-66

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
XANTHAN GUMTTV12P4NEEIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCLReckitt Benckiser LLC4df37cfb-299f-661f-e063-6394a90ab3372026-06-04WarningsExact identifier
ndc (package): 63824-019-66
ndc11 (package): 63824001966
Mucinex Fast-Max DM MaxDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC6a8cdcad-4881-49b8-a3f1-2c1574300d182026-05-13WarningsExact identifier
ndc (package): 63824-019-66
ndc (product): 63824-019
ndc11 (package): 63824001966
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc2026-05-13WarningsExact identifier
ndc (package): 63824-503-66
ndc11 (package): 63824050366
Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3ba2cc08-acad-79a8-e063-6394a90af17f2026-05-13WarningsExact identifier
ndc (package): 63824-019-66
ndc (package): 63824-503-66
ndc11 (package): 63824001966
ndc11 (package): 63824050366
Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC2ed3c844-0532-40d9-beba-738d196de34d2026-05-13WarningsExact identifier
ndc (package): 63824-019-66
ndc (package): 63824-118-66
ndc (package): 63824-503-66
ndc (product): 63824-118
ndc11 (package): 63824001966
ndc11 (package): 63824050366
ndc11 (package): 63824011866
spl id: 51b4756d-c887-a57d-e063-6394a90a6e72
spl set id: 2ed3c844-0532-40d9-beba-738d196de34d
Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa51b6312-598e-4a25-a873-6b59bc87d9002026-05-13WarningsExact identifier
ndc (package): 63824-503-66
ndc (product): 63824-503
ndc11 (package): 63824050366
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC4592d547-556f-4eec-8faf-6ff9a92e46c82026-04-08WarningsExact identifier
ndc (package): 63824-503-66
ndc11 (package): 63824050366

Reported adverse events (FAERS/openFDA)#

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