FDA Label for Nasal Decongestant

View Indications, Usage & Precautions

Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Navarro Discount Pharmacies,llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Oxymetazoline HCl 0.05%


Purpose



Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
    • sinusitis
      • reduces swelling of nasal passages; shrinks swollen membranes
      • temporarily restores freer breathing through the nose

Warnings



Do not use this product for more than 3 days


Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate

When Using This Product



  • do not exceed recommended dosage
  • use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen
  • temporary discomfort such as burning, stinging, or an increase in nasal discharge may occur
  • 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 right away.


Directions



  • To spray, squeeze bottle qiuckly and firmly
  • Do not tilt head backward while spraying
  • Wipe nozzle clean after use
  • 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
  • chlidren under 6 years of age: ask a doctor



Other Information



  • store at room temperature 15° - 30°C (59°-86°F)
    • retain carton for future reference on full labeling

Inactive Ingredients



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


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