FDA.reportPublic FDA data

Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:57:14

Label at a glance#

ProductMucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum Strength
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves: nasal congestion headache minor aches and pains cough sinus congestion and pressure temporarily promotes nasal and/or sinus drainage 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 minor aches and pains sore throat heada...

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

OTC - PURPOSE SECTION

Active ingredients (in each caplet)
Mucinex Sinus-Max Day Pressure, Pain & Cough 		Purposes
Acetaminophen 325 mgPain reliever
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each caplet)
Mucinex Nightshift Night Sinus 		Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant
Triprolidine HCl 1.25 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

Mucinex Sinus-Max Day Pressure, Pain & Cough

SPL UNCLASSIFIED SECTION

  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • cough
    • sinus congestion and pressure
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Mucinex Nightshift Night Sinus

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 (Nightshift Night Sinus 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.
  • 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 Sinus only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Night Sinus 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 Sinus only)

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Night Sinus only)
  • marked drowsiness may occur (Nightshift Night Sinus only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Night Sinus only)
  • avoid alcoholic drinks (Nightshift Night Sinus only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Night Sinus 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 Sinus-Max Day Pressure, Pain & Cough

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 Sinus

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

INACTIVE INGREDIENT SECTION

SPL UNCLASSIFIED SECTION

Mucinex Sinus-Max Day Pressure, Pain & Cough

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

INACTIVE INGREDIENT SECTION

SPL UNCLASSIFIED SECTION

Mucinex Nightshift Night Sinus

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? 1-866-MUCINEX (1-866-682-4639)

OTC - QUESTIONS SECTION

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

FAST RELEASE. POWERFUL SYMPTOM RELIEF!

NDC 72854-243-20

MAXIMUM STRENGTH

Mucinex®

SINUS-MAX®
NIGHTSHIFT

DAY
PRESSURE, PAIN & COUGH

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

  • Relieves Sinus Pressure
    & Congestion
  • Relieves Headache
  • Controls Cough
  • Thins & Loosens Mucus

ACTUAL SIZE

FOR AGES 12+

12 CAPLETS

NIGHT
SINUS

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

NIGHTTIME
RELIEF FOR A BETTER
MORNING

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

ACTUAL SIZE

FOR AGES 12+

8 CAPLETS

FAST
RELEASE

TOTAL 20 CAPLETS

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2560237{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) } PackGPCK5
25602371 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) PackPSN5
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN5
2549037acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral TabletPSN5
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD5
2549037acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCD5
25602371 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) PackSY5
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY5
2549037APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral TabletSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72854-243-102023-05-11C16284748780-1f386c649-ee45-0266-e053-dadaa90a7c1aMucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-202023-05-11C16284748780-1f386c649-ee45-0266-e053-dadaa90a7c1aMucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-402023-05-11C16284748780-1f386c649-ee45-0266-e053-dadaa90a7c1aMucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-102023-01-30C16284748780-1f386c649-ee45-0266-e053-dadaa90a7c1aMucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-202023-01-30C16284748780-1f386c649-ee45-0266-e053-dadaa90a7c1aMucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-402023-01-30C16284748780-1f386c649-ee45-0266-e053-dadaa90a7c1aMucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-243-10Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength1 in 1 CARTONKIT15
72854-243-10Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength1 in 1 KITKIT15
72854-243-20Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength2 in 1 CARTONKIT25
72854-243-20Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength1 in 1 KITKIT15
72854-243-40Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength4 in 1 CARTONKIT45
72854-243-40Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength1 in 1 KITKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-243-10EA - Each72854-243aebd8ba4-a7b5-468b-8846-20ca216b2b8612021-10-08
72854-243-20EA - Each72854-2439ca63b05-8d66-4da3-87d9-9aab1fe3324812021-10-08
72854-243-40EA - Each72854-24350de03e3-1278-413a-8cb8-acf7f492f34512021-10-08
63824-242-20EA - Each63824-242261e3a9e-b9e6-4189-bd87-25634bf39e1512019-11-12
72854-240-20EA - Each72854-240478236c0-ab5b-478b-8464-815d507b260312021-10-08

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-24372854-243-10, 72854-243-20, 72854-243-40
63824-242
72854-240

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ALUMINUM OXIDELMI26O6933IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
FERRIC OXIDE RED1K09F3G675IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)23ZQ42JZZHIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB

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 Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC09fdf96f-345f-43f2-9f0f-8303ac70849e2026-05-13WarningsExact identifier
ndc (product): 72854-240
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd03ef2fd-1a08-42c0-b69d-fd4e4285ccd32026-05-12WarningsExact identifier
ndc (product): 63824-242
Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCc746953f-4b7d-4e2a-9b85-96bd6901f5172026-05-12WarningsExact identifier
ndc (package): 72854-243-20
ndc (package): 72854-243-10
ndc (package): 72854-243-40
ndc (product): 72854-243
ndc11 (package): 72854024320
ndc11 (package): 72854024340
ndc11 (package): 72854024310
spl id: 51a483c2-9a2c-2c7a-e063-6294a90aaa3a
spl set id: c746953f-4b7d-4e2a-9b85-96bd6901f517

Reported adverse events (FAERS/openFDA)#

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