Label: MEDIX NASAL DECONGESTANT OXYMETAZOLINE HYDROCHLORIDE- oxymetazoline hydrochloride liquid

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

Drug Label Information

Updated January 8, 2024

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!