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Name:Nostrilla
Manufacturer:Insight Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


Nōstrilla® oxymetazoline HCl USP 0.05%

NOSTRILLA - oxymetazoline hydrochloride spray, metered 
Insight Pharmaceuticals

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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Nōstrilla®
oxymetazoline HCl USP 0.05%

Drug Facts

Active Ingredient (per spray)              Purpose
oxymetazoline hydrochloride 0.05% . . . . . . . . . . . . Nasal decongestant

Uses

for temporary relief of nasal congestion

  • due to a cold
  • due to hay fever or other upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely

Warnings

For nasal use only. 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. Frequent or prolonged use may cause nasal congestion to come back or get worse.
  • use only as directed

Stop use and ask a doctor if symptoms persist

The use of this container 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

do not exceed 2 doses in any 24 hour period

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.
children under 6 years of age ask a doctor

Inactive Ingredients

benzalkonium chloride solution, camphor, carbomer 934P, carboxymethylcellulose sodium, edetate disodium, eucalyptol, glycine, hyaluronic acid sodium, menthol, polyethylene glycol, propylene glycol, sodium hydroxide, water.

PRINCIPAL DISPLAY PANEL - 1/2 FL. OZ. Bottle Carton

NASAL
DECONGESTANT

Nōstrilla®
oxymetazoline HCl USP 0.05%

COMPLETE
Congestion Relief

2 in 1 Formula
Relieves Severe
Congestion and
Moisturizes

No-Drip Formula

12 HOUR

1/2 FL. OZ.
(15 ML)

PRINCIPAL DISPLAY PANEL - 1/2 FL. OZ. Bottle Carton

NOSTRILLA 
oxymetazoline hydrochloride spray, metered
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-072
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxymetazoline Hydrochloride (Oxymetazoline) Oxymetazoline 0.0005 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride  
camphor  
carboxymethylcellulose sodium  
edetate disodium  
eucalyptol  
glycine  
menthol  
polyethylene glycol  
propylene glycol  
sodium hydroxide  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-072-01 1 BOTTLE, SPRAY ( BOTTLE) in 1 CARTON contains a BOTTLE, SPRAY
1 15 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (63736-072-01)

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 (176792315)

Revised: 06/2009 Insight Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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