Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain Clear and Cool

Manufacturer
RB Health (US) LLC
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:26:57

Label at a glance#

ProductMucinex-Sinus Max Severe Congestion and Pain Clear and Cool and Mucinex Nightshift Sinus Clear and Cool
Active ingredientGUAIFENESIN, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 sections

Indications and uses

Mucinex Sinus-Max SEVERE CONGESTION & PAIN CLEAR & COOL 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 Mucinex Nightshift Sinus Clear & Cool temporarily relieve...

Dosage and administration

MUCINEX SINUS-MAX SEVERE CONGESTION & PAIN CLEAR & COOL ■ 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 over: 20 mL in dosing cup provided every 4 hours ■ children under 12 years of ag...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Mucinex Sinus-Max
SEVERE CONGESTION & PAIN CLEAR & COOL
Acetaminophen 650mg.......... ................Pain reliever
Guaifenesin 400 mg.................................Expectorant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant

Mucinex Nightshift
Sinus Clear & Cool
Acetaminophen 650mg..........Pain reliever/fever reducer
Dextromethorphan HBr 20 mg..............Cough suppressant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .. . .Nasal decongestant
Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . .Antihistamine

Uses

INDICATIONS & USAGE SECTION

Mucinex Sinus-Max SEVERE CONGESTION & PAIN
CLEAR & COOL
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

Mucinex Nightshift Sinus Clear & Cool
temporarily relieves these common cold and flu symptoms:
■ cough

■ nasal congestion

■ minor aches and pains
■ sore throat

■ headache
■ sinus congestion and pressure

■ 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 SECTION

Warnings
Liver warning: 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: 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 Sinus Clear & Cool only):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.

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.

Ask a doctor before use if you have
■ liver disease ■ heart disease ■ diabetes
■ high blood pressure
■ thyroid disease
■ glaucoma (Nightshift Sinus Clear & Cool only)
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
(Nightshift Sinus Clear & Cool 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
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers (Nightshift Sinus Clear & Cool only)

When using this product ■ do not use more than directed
■ excitability may occur, especially in children (Nightshift Sinus
Clear & Cool only)
■ marked drowsiness may occur (Nightshift Sinus Clear & Cool
only)
■ alcohol, sedatives, and tranquilizers may increase drowsiness
(Nightshift Sinus Clear & Cool only)
■ avoid alcoholic drinks (Nightshift Sinus Clear & Cool only)
■ use caution when driving a motor vehicle or operating machinery
(Nightshift Sinus Clear & Cool only)

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 fever, rash, or headache that lasts.
These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.


Keep out of reach of children.


Overdose warning: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 SEVERE CONGESTION & PAIN
CLEAR & COOL

■ 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 over: 20 mL in
dosing cup provided every 4 hours
■ children under 12 years of age: do not use


MUCINEX NIGHTSHIFT SINUS CLEAR & COOL
■ 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 SAFETY INFORMATION

■ each 20 mL contains: sodium
9mg (Severe Congestion & Pain
Clear & Cool only) and sodium
16mg (Nightshift Sinus Clear &
Cool only)
■ store at 20-25°C (68-77°F)
■ do not refrigerate

INACTIVE INGREDIENT SECTION

(Mucinex Sinus-Max
Severe Congestion & Pain
Clear & Cool)

anhydrous citric
acid, D&C yellow no. 10, edetate
disodium, FD&C blue no. 1,
flavors, glycerin, propyl gallate,
propylene glycol, purified water,
sodium benzoate, sorbitol,
sucralose, trisodium citrate
dihydrate*, xanthan gum
*may contain this ingredient

(Mucinex Nightshift
Sinus Clear & Cool)

ammonium glycyrrhizate,
anhydrous citric acid, D&C
yellow no. 10, edetate disodium,
FD&C blue no. 1, flavors,
glycerin (soy), propylene glycol,
sodium benzoate, sorbitol,
sucralose, water, xanthan gum

OTC - QUESTIONS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PURPOSE SECTION

Acetaminophen 650mg.......... ................Pain reliever
Guaifenesin 400 mg.................................Expectorant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant

Acetaminophen 650mg..........Pain reliever/fever reducer
Dextromethorphan HBr 20 mg..............Cough suppressant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .. . .Nasal decongestant
Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . .Antihistamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabelLabelLabelLabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-116-66ML - Milliliter63824-116bd5efa46-508f-4285-9642-75fbfb064f9f12023-05-05
63824-270-66ML - Milliliter63824-27053f657d1-b985-4b28-93fa-083639692ec312020-06-05

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
63824-11663824-116-66
63824-26763824-267-66
63824-27063824-270-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
03b03099-3138-db34-e063-6394a90a285cf9ca13f8-1046-3791-e053-6394a90af08a2023-08-24WarningsExact identifier
spl id: 03b03099-3138-db34-e063-6394a90a285c
spl set id: f9ca13f8-1046-3791-e053-6394a90af08a

Reported adverse events (FAERS/openFDA)#

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