SINUFRIN QUICK RELIEF DECONGESTANT- sinufrin spray

Sinufrin Quick Relief Decongestant by

Drug Labeling and Warnings

Sinufrin Quick Relief Decongestant by is a Otc medication manufactured, distributed, or labeled by Neilmed pharmaceuticals Inc., NeilMed Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredients

Oxymetazoline hydrochloride 0.04%

Purpose

Nasal Decongestant

Uses:

• Temporarily relieves nasal congestion due to:
• Common cold
• Hay fever
• Upper respiratory allergies
• Temporarily relieves sinus congestion and pressure
• Shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

• Heart disease
• High blood pressure
• Diabetes
• Thyroid disease
• Trouble urinating due to an enlarged prostate gland

When using this product

• Do not use more than directed
• Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• Temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
• Use of this container by more than one person may spread infection.

Warnings

​Stop use and ask a doctor if symptoms persist

Warnings

If pregnant or breast-feeding, ask a health professional before use.

Warnings

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): 3 or 4 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: ask a doctor To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

OTHER SAFETY INFORMATION

Other Information

• Store between 68° F (20° C) and 86° F (30° C)
• Retain carton for future reference on full labeling

Inactive Ingredients

Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water.

Principal Display Panel

INGREDIENTS AND APPEARANCE

SINUFRIN QUICK RELIEF DECONGESTANT 
sinufrin spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-325
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE (UNII: 8VLN5B44ZY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE	0.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-325-01	1 in 1 CARTON	12/11/2023
1		15 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	12/11/2023

Labeler - Neilmed pharmaceuticals Inc. (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
NeilMed Pharmaceuticals Inc.		799295915	manufacture(13709-325)