SINUFRIN NEILMED- oxymetazoline hydrochloride spray 
NeilMed Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

SinuFrin bottle label

Box label

image description

SINUFRIN  NEILMED
oxymetazoline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13709-231
Route of Administration NASAL DEA Schedule CII    
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
2 NDC:13709-231-04 15 mL in 1 BOX
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 (783557783)
Registrant - NeilMed Pharmaceuticals Inc (783557783)
Establishment
Name Address ID/FEI Business Operations
NeilMed Pharmaceuticals Inc 783557783 manufacture(13709-231)

Revised: 9/2012
Document Id: 46549bdf-f029-47a9-987a-3c4cad9659fb
Set id: f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae
Version: 1
Effective Time: 20120919
 
NeilMed Pharmaceuticals Inc