NOSTRILLA- oxymetazoline hydrochloride spray, metered

Nostrilla by

Drug Labeling and Warnings

Nostrilla by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (per spray)

oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to:
  ▪ a cold
  ▪ hay fever
  ▪ upper respiratory allergies
  ▪ helps clear nasal passages; shrinks swollen membranes
  ▪ temporarily restores freer breathing through the nose

Warnings

Ask a doctor before use if you have

• heart disease
  
• thyroid disease
  
• high blood pressure
  
• diabetes
  
• trouble urinating due to an enlarged prostate gland

When using this product

• do not exceed recommended dosage
  
• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  
• use of this container 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 (1-800-222-1222) 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: ask a doctor

Squeeze and unscrew to remove the protective cap. Align rail grooves and prime pump by depressing it firmly several times (see illustration on side). Hold bottle with thumb at base and nozzle between first and second fingers. With head upright, insert nozzle into nostril. Depress pump two or three times, all the way down, and sniff deeply.

Other Information

• store between 20° – 25°C (68° – 77°F). Avoid excessive heat or freezing.
  
• keep carton for full drug facts

Inactive ingredients

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Questions or comments?

1-800-344-7239

PRINCIPAL DISPLAY PANEL

Nōstrilla® 
Oxymetazoline HCl Nasal Solution
NASAL DECONGESTANT
1/2 FL. OZ (15 mL)

INGREDIENTS AND APPEARANCE

NOSTRILLA 
oxymetazoline hydrochloride spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-730
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-730-01	1 in 1 CARTON	06/08/2009
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 63736-730-02	1 in 1 CARTON	06/08/2009
2		22.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/08/2009

Labeler - Insight Pharmaceuticals LLC (055665422)