Oxymetazoline hydrochloride, Acetaminophen and Guaifenesin

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:58:18

Label at a glance#

ProductMucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool
Active ingredientGUAIFENESIN, ACETAMINOPHEN, OXYMETAZOLINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children

OTC - PURPOSE SECTION

Purpose


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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelcarton label

back labelback label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN3
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN3
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD3
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363824999500GTIN-13: 0363824999500
EAN-13: 0363824999500
GTIN-12: 363824999500
UPC-A: 363824999500
GTIN storage (14 digits): 00363824999500
72854-212 label front.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-129-17Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool22 mL in 1 BOTTLE, PUMPSOLUTION1 mL0.05 g in 100mL3
63824-129-17Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool1 in 1 CARTONSOLUTION0.05 g in 100mL3
72854-211-16Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool16 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1325 mg3
72854-211-16Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool1 in 1 CARTONCAPSULE, LIQUID FILLED325 mg3
72854-212-02Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-129-17ML - Milliliter63824-129b2305dd6-0eb3-4c18-a9b1-70e28c61303312019-11-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-21272854-212-02
72854-21172854-211-16
63824-12963824-129-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC33f0d9bb-c67d-92ba-e063-6294a90a99432026-05-13WarningsExact identifier
ndc (package): 63824-129-17
ndc11 (package): 63824012917
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC373e0d75-8def-4b98-e063-6394a90a5e472026-05-13WarningsExact identifier
ndc (package): 72854-212-02
ndc (package): 63824-129-17
ndc (package): 72854-211-16
ndc (product): 72854-212
ndc11 (package): 63824012917
ndc11 (package): 72854021116
ndc11 (package): 72854021202
spl id: 51b4c3a0-ce94-6ac8-e063-6394a90a2d96
spl set id: 373e0d75-8def-4b98-e063-6394a90a5e47
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASALOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC5a397466-8721-4060-a178-5ebfd7069cc92026-05-13WarningsExact identifier
ndc (package): 63824-129-17
ndc (product): 63824-129
ndc11 (package): 63824012917
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
ndc (package): 72854-211-16
ndc (product): 72854-211
ndc11 (package): 72854021116

Reported adverse events (FAERS/openFDA)#

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