FDA.reportPublic FDA data

Mucinex® Sinus-Max®

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:57:08

Label at a glance#

ProductMaximum Strength Mucinex Sinus-Max Severe Congestion and Pain
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves: nasal congestion headache minor aches and pains 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

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

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)Purposes
Acetaminophen 325 mgPain reliever
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • 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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 12 caplets 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.

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
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • diabetes
  • 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

OTC - WHEN USING SECTION

When using this product do not use more than directed

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

  • 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

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

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

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 - 20 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

NDC 63824-241-20

Mucinex®

SINUS-MAX®

SEVERE CONGESTION & PAIN

Acetaminophen – Pain Reliever • Guaifenesin – Expectorant

Phenylephrine HCl – Nasal Decongestant

  • Clears Sinus Congestion
  • Relieves Headache
  • Thins & Loosens Mucus

FOR AGES 12+

20 CAPLETS LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN8
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD8
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY8
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY8

DailyMed Pharmacologic Classes#

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

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
63824-241-202020-10-09C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-442020-10-09C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-722020-10-09C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-202020-09-27C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-442020-09-27C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-722020-09-27C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-202020-09-25C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-442020-09-25C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-722020-09-25C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-202020-07-22C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-442020-07-22C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain
63824-241-722020-07-22C16284748780-1ab0e2407-2f2a-f274-e053-dbdaa90a6471Mucinex® Sinus-Max® Severe Congestion and Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-241-10Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain1 in 1 CARTONTABLET, FILM COATED18
63824-241-10Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain10 in 1 BLISTER PACKTABLET, FILM COATED108
63824-241-20Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain2 in 1 CARTONTABLET, FILM COATED28
63824-241-20Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain10 in 1 BLISTER PACKTABLET, FILM COATED108
63824-241-44Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain2 in 1 POUCHTABLET, FILM COATED28
63824-241-44Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain4 in 1 CARTONTABLET, FILM COATED48
63824-241-72Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain2 in 1 POUCHTABLET, FILM COATED28

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-24163824-241-20, 63824-241-72, 63824-241-44, 63824-241-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
Maximum Strength Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2ef9d5de-e99e-4398-bf97-c7bef94498fa2026-05-12WarningsExact identifier
ndc (package): 63824-241-44
ndc (package): 63824-241-10
ndc (package): 63824-241-72
ndc (package): 63824-241-20
ndc (product): 63824-241
ndc11 (package): 63824024144
ndc11 (package): 63824024172
ndc11 (package): 63824024110
ndc11 (package): 63824024120
spl id: 51a49072-914b-892d-e063-6294a90a641f
spl set id: 2ef9d5de-e99e-4398-bf97-c7bef94498fa