SINUFRIN NEILMED- oxymetazoline hydrochloride spray

SinuFrin by

Drug Labeling and Warnings

SinuFrin by is a Otc medication manufactured, distributed, or labeled by NeilMed Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

0.05% Oxymetazoline Hydrochloride

Uses

temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies

Warnings

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.

Warnings

Do not use this product for more than 3 consecutive days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease or diabetes unless directed by a doctor.

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.

Other Information

Store between 20 to 40 °C (68 to 104 °F)
Retain carton for future reference on full labeling

Warnings

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

Do not use this product for more than 3 consecutive days. Use only as directed. Frequent or prolonged use may
cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. Do not use this product if you have heart disease, high
blood pressure, thyroid disease or diabetes unless directed by a doctor. Adult males with prostate disease, do not use this product.

Other Information

Keep head in an upright position for use. Do not tilt head backward while spraying. Wipe nozzle clean after each use.

Warnings

Stop using this product for more than 3 consecutive days. Stop and ask your doctor if symptoms of nasal congestion persist after using 3 consecutive days.

Warnings

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

Uses

temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies.

Inactive Ingredients

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

Principal Display label

Box label

INGREDIENTS AND APPEARANCE

SINUFRIN  NEILMED
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-231
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)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-231-07	15 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	07/15/2012
2	NDC: 13709-231-04	15 mL in 1 BOX; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	07/15/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/15/2012

Labeler - NeilMed Pharmaceuticals Inc (799295915)

Registrant - NeilMed Pharmaceuticals Inc (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
NeilMed Pharmaceuticals Inc		799295915	manufacture(13709-231)