SINUFRIN DECONGESTANT- nasal congestion relief solution

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredients

Oxymetazoline hydrochloride 0.05%

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 n High blood pressure
• Thyroid disease
• Diabetes
• 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 product by more than one person may spread infection

Stop use and ask a doctor if symptoms persist
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Ask a doctor before use if you have

Heart disease

High blood pressure

Thyroid disease

Diabetes

Trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if

symptoms persist

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 product by more than one person may spread infection

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions for Dosing

Adults and children 6 to 12 years of age (with adult supervision):
Per dose, 2 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 n To use: To spray, squeeze bottle quickly and firmly. Keep head
upright and do not tilt head backward while spraying. Wipe nozzle clean after use.
Secure cap after use.

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

Uses

Adults and children 6 to 12 years of age (with adult supervision)

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

Dosage and Administration

Oxymetazoline hydrochloride 0.05%

Each full spray releases 0.1 mL of solution

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

Do Not Use

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.

Package Label

INGREDIENTS AND APPEARANCE

SINUFRIN DECONGESTANT 
nasal congestion relief solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-355
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	7.5 mg  in 15 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-355-01	1 in 1 CARTON	05/25/2026
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	05/25/2026

Labeler - NeilMed Pharmaceuticals Inc (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
NeilMed Pharmaceuticals Inc		799295915	manufacture(13709-355)