MUCINEX RAPID CLEAR PAIN, HEADACHE, AND MUCUS CONGESTION AND SINUS MAX CLEAR AND COOL- oxymetazoline hydrochloride, acetaminophen and guaifenesin kit

Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool by

Drug Labeling and Warnings

Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INDICATIONS & 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

WARNINGS

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.

DOSAGE & 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

OTHER SAFETY INFORMATION

Other information
■ store at 20-25°C (68-77°F)

■ avoid excessive heat

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children

PURPOSE

Purpose

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

Acetaminophen 325 mg.........................................Pain reliever/fever reducer
Guaifenesin 200 mg...................................................................Expectorant

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCINEX RAPID CLEAR PAIN, HEADACHE, AND MUCUS CONGESTION AND SINUS MAX CLEAR AND COOL 
oxymetazoline hydrochloride, acetaminophen and guaifenesin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-212

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-212-02	1 in 1 CARTON	05/01/2025
1		1 in 1 CARTON; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BLISTER PACK	1
Part 2	0 BOTTLE, PUMP	1 mL

Part 1 of 2

MUCINEX SINUS MAX CLEAR AND COOL 
acetaminophen and guaifenesin capsule, liquid filled

Product Information
Item Code (Source)	NDC: 72854-211
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	23mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-211-16	1 in 1 CARTON
1		16 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/01/2025

Part 2 of 2

MUCINEX SINUS-MAX  SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL NASAL
oxymetazoline hydrochloride solution

Product Information
Item Code (Source)	NDC: 63824-129
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZODODECINIUM CHLORIDE (UNII: Y5A751G47H)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-129-17	1 in 1 CARTON
1		22 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/01/2025

Labeler - RB Health (US) LLC (081049410)