Mucinex Sinus Max Sinus Pressure Severe Congestion

Mucinex Sinus Max Sinus Pressure Severe Congestion
SPL v2
SPL
SPL Set ID 2eeafd83-230c-af92-e063-6294a90a984e
Route
NASAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Benzododecinium Chloride Phosphorus Pentoxide Cetalkonium Chloride Sodium Phosphate, Dibasic, Anhydrous Glycerin Myristalkonium Chloride Sodium Oxide Propylene Glycol Sorbitol Edetate Disodium Sodium Phosphate, Monobasic, Unspecified Form Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Drug Facts


Medication Information

Warnings and Precautions



Warnings

Ask a doctor before use if you have

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ difficulty in urination due to enlargement of the

prostate gland



When using this product

■ do not exceed recommended dosage

■ do not use this product for more than 3 days. Use

only as directed. Frequent or prolonged use may

cause nasal congestion to recur or worsen.

■ this product may cause temporary discomfort such

as burning, stinging, sneezing, or an increase in

nasal discharge

■ the use of this container by more than one person

may spread infection

Stop use and ask a doctor if symptoms persist

Indications and Usage

Purpose:

Nasal Decongestant

Uses:

■ temporarily relieves nasal congestion due to:

■ a cold

■ hay fever or other upper respiratory allergies

■ promotes nasal and/or sinus drainage; temporarily

relieves sinus congestion and pressure

■ helps clear nasal passages; shrinks swollen membranes

Dosage and Administration



Directions

■ adults and children 6 to under 12 years of age (with

adult supervision): 2 or 3 sprays in each nostril, not

more often than every 10 to 12 hours. Do not exceed

2 doses in any 24-hour period.

■ children under 6 years of age: consult a doctor.



Shake well before use.

To open, hold by the white grips then squeeze, push down

firmly and turn cap counterclockwise. Before using for the

first time, remove the protective cap from the tip and

prime metered pump by depressing firmly several times.

To spray, hold bottle with thumb at the base and nozzle

between first and second fingers.Without tilting head,

insert nozzle into nostril. Fully depress pump all the way

down with a firm even stroke and sniff deeply.



Wipe nozzle clean after use. To

close, turn cap clockwise.

DO NOT DISCARD CAP.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1



Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

Section 51727-6



Inactive ingredients

benzalkonium chloride,

benzododecinium chloride,

cetalkonium chloride, dibasic

sodium phosphate anhydrous,

edetate disodium, glycerin,

monobasic sodium phosphate

anhydrous, myristalkonium

chloride, phosphorous pentoxide,

propylene glycol, purified water,

sodium oxide, sorbitol

Section 51945-4

Section 53413-1



Questions?

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



Dist. by: RB Health (US)

Parsippany NJ 07054-0224

Section 53414-9



If pregnant or breast-feeding, ask a health professional

before use.

Section 55105-1

Purpose:

Nasal Decongestant

Section 55106-9

Active ingredient

Oxymetazoline hydrochloride 0.05%

Section 60561-8



Other information

■ store at 20-25°C (68-77°F)


Structured Label Content

Indications and Usage (34067-9)

Purpose:

Nasal Decongestant

Uses:

■ temporarily relieves nasal congestion due to:

■ a cold

■ hay fever or other upper respiratory allergies

■ promotes nasal and/or sinus drainage; temporarily

relieves sinus congestion and pressure

■ helps clear nasal passages; shrinks swollen membranes

Dosage and Administration (34068-7)



Directions

■ adults and children 6 to under 12 years of age (with

adult supervision): 2 or 3 sprays in each nostril, not

more often than every 10 to 12 hours. Do not exceed

2 doses in any 24-hour period.

■ children under 6 years of age: consult a doctor.



Shake well before use.

To open, hold by the white grips then squeeze, push down

firmly and turn cap counterclockwise. Before using for the

first time, remove the protective cap from the tip and

prime metered pump by depressing firmly several times.

To spray, hold bottle with thumb at the base and nozzle

between first and second fingers.Without tilting head,

insert nozzle into nostril. Fully depress pump all the way

down with a firm even stroke and sniff deeply.



Wipe nozzle clean after use. To

close, turn cap clockwise.

DO NOT DISCARD CAP.

Warnings and Precautions (34071-1)



Warnings

Ask a doctor before use if you have

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ difficulty in urination due to enlargement of the

prostate gland



When using this product

■ do not exceed recommended dosage

■ do not use this product for more than 3 days. Use

only as directed. Frequent or prolonged use may

cause nasal congestion to recur or worsen.

■ this product may cause temporary discomfort such

as burning, stinging, sneezing, or an increase in

nasal discharge

■ the use of this container by more than one person

may spread infection

Stop use and ask a doctor if symptoms persist

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)



Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)



Inactive ingredients

benzalkonium chloride,

benzododecinium chloride,

cetalkonium chloride, dibasic

sodium phosphate anhydrous,

edetate disodium, glycerin,

monobasic sodium phosphate

anhydrous, myristalkonium

chloride, phosphorous pentoxide,

propylene glycol, purified water,

sodium oxide, sorbitol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)



Questions?

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



Dist. by: RB Health (US)

Parsippany NJ 07054-0224

Section 53414-9 (53414-9)



If pregnant or breast-feeding, ask a health professional

before use.

Section 55105-1 (55105-1)

Purpose:

Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredient

Oxymetazoline hydrochloride 0.05%

Section 60561-8 (60561-8)



Other information

■ store at 20-25°C (68-77°F)


Advanced Ingredient Data


Raw Label Data

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