Label: MUCINEX RAPID CLEAR PAIN, HEADACHE, AND MUCUS CONGESTION AND SINUS MAX CLEAR AND COOL- oxymetazoline hydrochloride, acetaminophen and guaifenesin kit
- NDC Code(s): 63824-129-17, 72854-211-08, 72854-216-02
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 29, 2025
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ACTIVE INGREDIENT
Active ingredient Purpose
Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestantActive 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 membranesUses
■ 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 infectionWarnings
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
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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 acidInactive 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
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUCINEX RAPID CLEAR PAIN, HEADACHE, AND MUCUS CONGESTION AND SINUS MAX CLEAR AND COOL
oxymetazoline hydrochloride, acetaminophen and guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-216 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-216-02 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 BOTTLE, PUMP 1 mL Part 2 0 BLISTER PACK 1 Part 1 of 2 MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL NASAL
oxymetazoline hydrochloride solutionProduct 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) CAMPHOR (NATURAL) (UNII: N20HL7Q941) BENZODODECINIUM CHLORIDE (UNII: Y5A751G47H) 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 Part 2 of 2 MUCINEX SINUS MAX CLEAR AND COOL
acetaminophen and guaifenesin capsule, liquid filledProduct 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) POVIDONE (UNII: FZ989GH94E) SORBITOL SOLUTION (UNII: 8KW3E207O2) LIGHT MINERAL OIL (UNII: N6K5787QVP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:72854-211-08 1 in 1 CARTON 1 8 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 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)


