FDA Label for Cvs Health Sinus Relief

View Indications, Usage & Precautions

Cvs Health Sinus Relief Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy,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



Oxymetazoline hydrochloride 0.05%


Purpose



Nasal Decongestant


Uses



  • •for the temporary relief of sinus/ nasal congestion due to:
  • •colds
  • •hay fever
  • •upper respiratory allergies

Ask A Doctor Before Use If You Have



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

When Using This Product



  • do not exceed recommended dosage
  • •use of this container by more than one person may spread infection.
  • •temporary burning, stinging, sneezing or increase in nasal discharge may occur
  • •frequent or prolonged use may cause nasal congestion to recur or worsen

Stop Use And Ask A Doctor



If Symptoms persist for more than 3 days


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of accidental ingestion, get medical help or contact a Poison Control Center right away. ( 1-800-222-1222)


Directions



  • •adults and children 6 yrs, & older (with adult supervision): 2 or 3 sprays in each nostril without tilting your head, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 hours.
  • •children 2 to under 6 yrs : ask a doctor
  • •children under 2 yrs: Do not use

Other Information



  • store at room temperature

Inactive Ingredients



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


Principal Display Panel



CVS Health

Compare to the active ingredient in Vicks® Sinex® *

Nasal Spray

Sinus Relief

OXYMETAZOLINE HCl 0.05%

Nasal decongestant

12 HOUR

NASAL SPRAY FOR SINUS RELIEF

12 Hour

1/2 FL OZ (15 mL)

DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSNG

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks®Sinex®

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2015 CVS/pharmacy

CVS.com®

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V-12431

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