Cvs Health Sinus Relief Spray
FDA Label NDC 59779-787

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy,inc. for the product Cvs Health Sinus Relief (NDC 59779-787). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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Cvs Health Sinus Relief  Oxymetazoline HCl 0.05% 15 mL (Image 01)

Cvs Health Sinus Relief Oxymetazoline HCl 0.05% 15 mL (Image 01)

* Please review the disclaimer below.