FDA Label for Oxymetazoline Hydrochloride

View Indications, Usage & Precautions

Oxymetazoline Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc. 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                         Purpose



Oxymetazoline HCI 0.05% ....... Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies 
    • temporarily relieves sinus congestion and pressure
    • shrinks swollen nasal membranes so you can breathe more freely

Warningsask 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 use more than directed
  • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 10-12 hours. Do not exceed 2 doses in any 24-hour period. 
  • children under 6 years of age: ask a doctor
  • Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides and turn in a counter-clockwise direction and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap back onto the bottle.

Other Information



  • store between 20° -25°C (68°-77 °F)
  • retain carton for future reference on full labeling
  • Questions or comments?
    1-800-935-2362 (Mon-Fri 9am-5pm EST)


Inactive Ingredients



avicel, benzalkonium chloride, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium dihydrate, eucalyptol, menthol, monobasic sodium phosphate, polyethylene glycol, povidone, purified water


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