Mucinex Sinus Max Clear & Cool Severe Congestion

Mucinex Sinus Max Clear & Cool Severe Congestion
SPL v1
SPL
SPL Set ID 2ee95e17-bd94-d717-e063-6294a90a2173
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
Cetalkonium Chloride Edetate Disodium Eucalyptol Linoleic Acid Menthol, Unspecified Form Myristic Acid Oleic Acid Water Polyethylene Glycol, Unspecified Polysorbate 80 Sodium Chloride Sodium Hydroxide Stearic Acid Myristalkonium Chloride Benzalkonium Chloride Benzododecinium Chloride Camphor, (-)- Silicon Dioxide Glycine Palmitic Acid Propylene Glycol Linolenic Acid Palmitoleic Acid Sodium Carbonate

Identifiers & Packaging

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

Description

Active ingredient Oxymetazoline hydrochloride 0.05%


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

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.

Description

Active ingredient Oxymetazoline hydrochloride 0.05%

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,

camphor, cetalkonium chloride,

colloidal silicon dioxide, edetate

disodium, eucalyptol, glycine,

linoleic acid, linolenic acid,

menthol, myristalkonium

chloride, myristic acid, oleic

acid, palmitic acid, palmitoleic

acid, polyethylene glycol,

polysorbate 80, propylene glycol,

purified water, sodium

carbonate, sodium chloride,

sodium hydroxide, stearic acid

Section 51945-4

Section 53413-1

Questions?

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional

before use.

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

help or contact a Poison Control Center right away.

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)

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.

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 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,

camphor, cetalkonium chloride,

colloidal silicon dioxide, edetate

disodium, eucalyptol, glycine,

linoleic acid, linolenic acid,

menthol, myristalkonium

chloride, myristic acid, oleic

acid, palmitic acid, palmitoleic

acid, polyethylene glycol,

polysorbate 80, propylene glycol,

purified water, sodium

carbonate, sodium chloride,

sodium hydroxide, stearic acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional

before use.

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

help or contact a Poison Control Center right away.

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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