Mucinex® Rapid+clear Pain Headache & Mucus Congestion + Mucinex® Sinus-max® Severe Nasal Congestion Relief Clear & Cool Nasal Spray

Mucinex® Rapid+clear Pain Headache & Mucus Congestion + Mucinex® Sinus-max® Severe Nasal Congestion Relief Clear & Cool Nasal Spray
SPL v2
SPL
SPL Set ID 373e0d75-8def-4b98-e063-6394a90a5e47
Routes
ORAL NASAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Acetaminophen (325 mg) Oxymetazoline (0.05 g)
Inactive Ingredients
Gelatin Glycerin Hypromellose, Unspecified Polyethylene Glycol, Unspecified Propylene Glycol Fd&c Blue No. 1 Lecithin, Sunflower Sorbitol Solution Light Mineral Oil Titanium Dioxide Povidone Water Benzalkonium Chloride Benzododecinium Chloride Camphor (natural)

Identifiers & Packaging

Pill Appearance
Shape: oval Color: blue Size: 23 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Active ingredient Purpose Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant Active ingredients (in each capsule) Purposes Acetaminophen 325 mg.........................................Pain reliever/fever reducer Guaifenesin 200 mg...................................................................Expectorant


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

Warnings

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

■ more than 12 capsules in 24 hours, which is the maximum daily amount for this product

■ 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: 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.

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.

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

Uses

■ temporarily relieves these common cold and flu symptoms:

■ minor aches and pains ■ headache ■ sore throat

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways

of bothersome mucus and make coughs more productive ■ temporarily reduces fever

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.

Directions

■ do not take more than directed (see Overdose warning)

■ do not take more than 12 capsules in any 24-hour period

■ adults and children 12 years of age and over: take 2 capsules every 4 hours

■ children under 12 years of age: do not use

Description

Active ingredient Purpose Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant Active ingredients (in each capsule) Purposes Acetaminophen 325 mg.........................................Pain reliever/fever reducer Guaifenesin 200 mg...................................................................Expectorant

Section 50565-1

Keep out of reach of Children

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

Inactive ingredients

FD&C blue no.1, gelatin, glycerin, hypromellose, lecithin, light mineral oil, polyethylene glycol,

povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Section 51945-4

Section 55105-1

Purpose



Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant

Acetaminophen 325 mg.........................................Pain reliever/fever reducer

Guaifenesin 200 mg...................................................................Expectorant

Section 55106-9

Active ingredient Purpose

Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant

Active ingredients (in each capsule) Purposes

Acetaminophen 325 mg.........................................Pain reliever/fever reducer

Guaifenesin 200 mg...................................................................Expectorant

Section 60561-8

Other information

■ store at 20-25°C (68-77°F)

■ avoid excessive heat


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

Uses

■ temporarily relieves these common cold and flu symptoms:

■ minor aches and pains ■ headache ■ sore throat

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways

of bothersome mucus and make coughs more productive ■ temporarily reduces fever

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.

Directions

■ do not take more than directed (see Overdose warning)

■ do not take more than 12 capsules in any 24-hour period

■ adults and children 12 years of age and over: take 2 capsules every 4 hours

■ children under 12 years of age: do not use

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

Warnings

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

■ more than 12 capsules in 24 hours, which is the maximum daily amount for this product

■ 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: 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.

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.

Section 50565-1 (50565-1)

Keep out of reach of Children

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

Inactive ingredients

FD&C blue no.1, gelatin, glycerin, hypromellose, lecithin, light mineral oil, polyethylene glycol,

povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose



Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant

Acetaminophen 325 mg.........................................Pain reliever/fever reducer

Guaifenesin 200 mg...................................................................Expectorant

Section 55106-9 (55106-9)

Active ingredient Purpose

Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant

Active ingredients (in each capsule) Purposes

Acetaminophen 325 mg.........................................Pain reliever/fever reducer

Guaifenesin 200 mg...................................................................Expectorant

Section 60561-8 (60561-8)

Other information

■ store at 20-25°C (68-77°F)

■ avoid excessive heat


Advanced Ingredient Data


Raw Label Data

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