MUCINEX® FAST-MAX® Daytime Cold & Flu & Nighttime Cold & Flu Caplets

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:58:03

Label at a glance#

ProductMucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache stuffy nose sinus congestion and pressure temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves these common cold and flu symptoms: cough nasal congestion min...

Dosage and administration

do not take more than directed (see Overdose warning ) do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets 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 8 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets every 4 hours child...

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Daytime Cold & Flu

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg


Mucinex Nighttime Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Triprolidine HCl 1.25 mg

OTC - PURPOSE SECTION

Active ingredients (in each caplet)

Mucinex Fast-Max Day Cold & Flu
Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Active ingredients (in each caplet)

Mucinex Nightshift Night Severe Cold & Flu
Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Triprolidine HCl 1.25 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

Mucinex Fast-Max Day Cold & Flu

SPL UNCLASSIFIED SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • stuffy nose
    • sinus congestion and pressure
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Mucinex Nightshift Night Severe Cold & Flu

SPL UNCLASSIFIED SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sneezing
    • sinus congestion and pressure
    • runny nose
    • 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

SPL UNCLASSIFIED SECTION

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4,000 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

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.

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.
  • 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
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma (Nightshift Night Severe Cold & Flu only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Night Severe 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
  • taking sedatives or tranquilizers (Nightshift Night Severe Cold & Flu only)

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 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.

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

Mucinex Fast-Max Day Cold & Flu

SPL UNCLASSIFIED SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Mucinex Nightshift Night Severe Cold & Flu

SPL UNCLASSIFIED SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 8 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients Mucinex Fast-Max Day Cold & Flu

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Inactive ingredients Mucinex Nightshift Night Severe Cold & Flu

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, ferric oxide, hydroxypropyl cellulose, mica, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol polyethylene glycol copolymer, povidone, silicon dioxide, stearic acid, talc, titanium dioxide

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

NDC 72854-169

Carton front labelCarton front label

combo back drug facts labelcombo back drug facts label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2717875{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Tablet) } PackGPCK5
27178751 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet) PackPSN5
2549034acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral TabletPSN5
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletPSN5
2549034acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCD5
2709673acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSCD5
27178751 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet) PackSY5
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletSY5
2549034APAP 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSY5
2709673APAP 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363824998978GTIN-13: 0363824998978
EAN-13: 0363824998978
GTIN-12: 363824998978
UPC-A: 363824998978
GTIN storage (14 digits): 00363824998978
72854-169 label front.jpg
QR code linkQR Codewww.mucinex.com/pages/product-faqs72854-169 back drug facts label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-169-10Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength1 in 1 CARTONKIT15
72854-169-10Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength1 in 1 KITKIT15
72854-169-20Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength1 in 1 KITKIT15
72854-169-20Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength2 in 1 CARTONKIT25
72854-169-40Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength1 in 1 KITKIT15
72854-169-40Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength4 in 1 CARTONKIT45

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-16972854-169-10, 72854-169-20, 72854-169-40
72854-161
72854-163

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC31ac6883-ffcd-39de-e063-6294a90a52dd2026-05-19WarningsExact identifier
ndc (product): 72854-161
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC326f1fd3-73ab-e515-e063-6294a90ab2222026-05-19WarningsExact identifier
ndc (package): 72854-169-10
ndc (package): 72854-169-20
ndc (package): 72854-169-40
ndc (product): 72854-169
ndc11 (package): 72854016940
ndc11 (package): 72854016920
ndc11 (package): 72854016910
spl id: 522dc3c2-13c5-efaa-e063-6394a90ae25d
spl set id: 326f1fd3-73ab-e515-e063-6294a90ab222
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC316b5569-b66f-f30c-e063-6394a90ae1472026-05-13WarningsExact identifier
ndc (product): 72854-163

Reported adverse events (FAERS/openFDA)#

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