FDA.reportPublic FDA data

Mucinex Sinus-Max

Manufacturer
Reckitt Benckiser LLC
Effective date
2016-05-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:25:33

Label at a glance#

ProductMucinex Sinus-Max Severe Congestion Relief Clear and Cool
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 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 older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

Storage and handling

each 20 mL contains: sodium 9 mg store between 20-25°C (68-77°F) dosing cup provided 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)Purposes
Acetaminophen 650 mgPain reliever
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 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 6 doses 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.

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
  • 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

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 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 older: 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 9 mg
  • store between 20-25°C (68-77°F)
  • dosing cup provided
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C yellow no. 10, edetate disodium, FD&C blue no. 1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, 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: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-265-66

MAXIMUM STRENGTH*

Mucinex®
SINUS-MAX®

SEVERE CONGESTION
RELIEF

CLEAR & COOL ™

Acetaminophen – Pain Reliever
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

  1. Clears Sinus Congestion
  2. Relieves Headache
  3. Thins & Loosens Mucus

6 FL OZ (180mL)
FOR AGES 12+

Principal Display Panel - 180 mL Bottle Label
Principal Display Panel - 180 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-265-662023-08-31C16284748780-19d75b9d0-c55f-f424-e053-dadaa90a57ceMucinex® Sinus-Max® Severe Congestion Relief Clear & Cool ™
63824-265-662020-01-31C16284748780-19d75b9d0-c55f-f424-e053-dadaa90a57ceMucinex® Sinus-Max® Severe Congestion Relief Clear & Cool ™

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-265-66ML - Milliliter63824-265926d0861-9070-4af4-a472-dde58611ec0d12017-08-11

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-26563824-265-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
anhydrous citric acidXF417D3PSLIACT
D&C yellow no. 1035SW5USQ3GIACT
edetate disodium7FLD91C86KIACT
FD&C blue no. 1H3R47K3TBDIACT
glycerinPDC6A3C0OXIACT
propyl gallate8D4SNN7V92IACT
propylene glycol6DC9Q167V3IACT
sodium benzoateOJ245FE5EUIACT
sodium citrate, unspecified form1Q73Q2JULRIACT
sorbitol506T60A25RIACT
sucralose96K6UQ3ZD4IACT
water059QF0KO0RIACT
xanthan gumTTV12P4NEEIACT

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
043ee8bb-6a7d-2040-e063-6294a90ab7582122da03-175e-44ce-8fef-b8763075c8132023-08-31WarningsExact identifier
spl set id: 2122da03-175e-44ce-8fef-b8763075c813

Reported adverse events (FAERS/openFDA)#

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