MEDIX NASAL DECONGESTANT OXYMETAZOLINE HYDROCHLORIDE- oxymetazoline hydrochloride liquid

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]

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:

INGREDIENTS AND APPEARANCE

MEDIX NASAL DECONGESTANT OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83522-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLUTATHIONE (UNII: GAN16C9B8O)
PYRROLOQUINOLINEDIONE TRICARBOXYLIC ACID (UNII: 47819QGH5L)
SODIUM NITRATE (UNII: 8M4L3H2ZVZ)
METHYL SALICYLATE (UNII: LAV5U5022Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83522-001-01	1 in 1 CARTON	09/10/2023
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/10/2023

Labeler - Medic -33, Inc. (116663992)

Establishment
Name	Address	ID/FEI	Business Operations
Recipharm Pharmaservices Private Limited		871401927	manufacture(83522-001)