Medix Nasal Decongestant Oxymetazoline Hydrochloride

Medix Nasal Decongestant Oxymetazoline Hydrochloride by

Drug Labeling and Warnings

Medix Nasal Decongestant Oxymetazoline Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Medic -33, Inc., Recipharm Pharmaservices Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDIX NASAL DECONGESTANT OXYMETAZOLINE HYDROCHLORIDE- oxymetazoline hydrochloride liquid 
Medic -33, Inc.

----------

Medix Nasal Decongestant Oxymetazoline Hydrochloride

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

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 DrugM01209/10/202309/11/2023
Labeler - Medic -33, Inc. (116663992)

Revised: 4/2025
 

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.