Label: MUCINEX CHILDRENS STUFFY NOSE- oxymetazoline hydrochloride solution

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

Drug Label Information

Updated December 27, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    • temporarily relieves nasal congestion due to:
      • a cold
      • hay fever or other upper respiratory allergies
    • promotes nasal and sinus drainage; temporarily relieves sinus congestion and pressure
    • helps clear nasal passages; shrinks swollen membranes
  • Warnings

    Ask a doctor before use if you or the child has

    • 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 ifsymptoms persist

    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.

  • 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 and turn cap. 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 until it "clicks".

    DO NOT DISCARD CAP

  • Other information

    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    benzalkonium chloride, camphor, edetate disodium, eucalyptol, glycine, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide

  • Questions?

    1-866-MUCINEX (1-866-682-4639)
    You may also report side effects to this number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

    Made in India

  • PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton

    NDC 63824-961-22

    Mucinex®

    Children's

    STUFFY NOSE
    SPRAY

    Oxymetazoline HCl 0.05%
    Nasal Decongestant

    12
    HOUR

    • Fast Relief
      of Stuffy Nose

    Ages 6+
    yrs

    3/4 FL OZ (22 mL)
    NASAL SPRAY

    PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX CHILDRENS STUFFY NOSE 
    oxymetazoline hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-961
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    GLYCINE (UNII: TE7660XO1C)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-961-221 in 1 CARTON03/30/2018
    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 DrugM01203/30/2018
    Labeler - RB Health (US) LLC (081049410)
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