Label: MEDIX NASAL DECONGESTANT OXYMETAZOLINE HYDROCHLORIDE- oxymetazoline hydrochloride liquid

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

Drug Label Information

Updated September 6, 2024

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  • Drug Facts

  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

    Purpose

    nasal decongestant

  • Uses

    • for the temporary relief of nasal congestion
    • temporarily restores freer breathing through the nose
  • Warnings

    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. If symptoms persist, consult a doctor.

    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.
    • 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.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact 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
  • Other information

    Do not use if the tamper-proof seal is damaged or broken.

  • Inactive ingredients

    Glutathione, menthol oil, pyrroloquinoline quinine, sodium nitrate, wintergreen oil, water.

  • Questions or Comments?

    305-861-1457

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MEDIX NASAL DECONGESTANT OXYMETAZOLINE HYDROCHLORIDE 
    oxymetazoline hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83522-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLUTATHIONE (UNII: GAN16C9B8O)  
    PYRROLOQUINOLINEDIONE TRICARBOXYLIC ACID (UNII: 47819QGH5L)  
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83522-001-011 in 1 CARTON09/10/2023
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/10/2023
    Labeler - Medic -33, Inc. (116663992)
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