FDA Label for Quality Choice

View Indications, Usage & Precautions

Quality Choice Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association. 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 hydrochloride 0.05%


Purpose



Nasal Decongestant


Uses



temporarily relieves nasal congestion due to:

  • •a cold
  • •hay fever
  • •upper respiratory allergies
  • •promotes nasal and sinus drainage
  • •temporarily relieves sinus congestion and pressure
  • •helps clear nasal passages; shrinks swollen nasal membranes

Ask A Doctor Before Use If You Have



  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •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

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 (1-800-222-1222).


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
  • Shake well before use: Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap.

    Rotate the lock tab to align arrow marks to unlock the pump. Prime the lock tab to align arrow marks to unlock the pump. Prime metered pump by depressing pump firmly several times.

    To spray, hold bottle with thump at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply.

    Wipe nozzle clean after use. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip.


Other Information



  • •store at room temperature
  • •retain carton for future reference on full labeling

Inactive Ingredients



benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.


Questions Or Comments?



1-866-467-2748


Principal Display Panel



NDC# 63868-699-22

QUALITY CHOICE®

*Compare to Active Ingredient in Mucinex® Full Force Nasal Spray

12 Hour Relief

Nasal Spray

Nasal Decongestant

Oxymetazoline HCl 0.05%

Fast Relief of Sinus Pressure & Nasal Congestion

3/4 FL OZ (22 mL)

100% QC SATISFACTION GUARANTEED

Distributed by C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Full Force™ Nasal Spray.


* Please review the disclaimer below.