CVS HEALTH SINUS RELIEF (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CVS PHARMACY,INC.]

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CVS HEALTH SINUS RELIEF (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CVS PHARMACY,INC.]
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NDC 59779-787-15
Set ID 3e15a1f9-c93e-4cdb-865c-68bfa63d3323
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy,Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • 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)
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