Label: CVS HEALTH SINUS RELIEF- oxymetazoline hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 2, 2016

If you are a consumer or patient please visit this version.

View All Sections
  • 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
  • Warnings

    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®

    1-800-SHOP CVS

    V-12431

    CVS Quality

    Money Back Guarantee

    CVS Health Sinus Relief Oxymetazoline HCl 0.05% 15 mL
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH SINUS RELIEF 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-787
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.00050 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-787-151 in 1 CARTON04/21/2015
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/21/2015
    Labeler - CVS Pharmacy,Inc. (062312574)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!