Label: MUCINEX SINUS MAX CLEAR AND COOL SEVERE CONGESTION- oxymetazoline hci spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 24, 2025

If you are a consumer or patient please visit this version.

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Oxymetazoline hydrochloride 0.05%

  • PURPOSE

    Purpose:

    Nasal Decongestant

  • 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

  • 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


    Stop use and ask a doctor if symptoms persist

  • 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.

  • OTHER SAFETY INFORMATION

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

  • 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

  • QUESTIONS

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

  • PREGNANCY OR BREAST FEEDING

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical
    help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    MUCINEX SINUS MAX CLEAR AND COOL SEVERE CONGESTION 
    oxymetazoline hci spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-218
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETALKONIUM CHLORIDE (UNII: 85474O1N9D)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MYRISTALKONIUM CHLORIDE (UNII: 0W255OL75T)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZODODECINIUM CHLORIDE (UNII: Y5A751G47H)  
    CAMPHOR, (-)- (UNII: 213N3S8275)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCINE (UNII: TE7660XO1C)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    PALMITOLEIC ACID (UNII: 209B6YPZ4I)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-218-111 in 1 CARTON06/01/2025
    122 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2025
    Labeler - RB Health (US) LLC (081049410)