Label: VICKS SINEX SEVERE ORIGINAL- oxymetazoline hydrochloride spray

  • NDC Code(s): 64336-170-01
  • Packager: Procter & Gamble Manufacturing GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Oxymetazoline HCl 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    temporarily relieves

    • nasal congestion due to a cold, hay fever, or other upper respiratory allergies
    • sinus congestion and pressure
  • Warnings

    Ask a doctor before use if you have

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

    When using this product

    • do not exceed recommended dosage
    • do not use this product 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 increased nasal discharge may occur
    • use of this container by more than one person may spread infection
  • STOP USE

    Stop use and ask a doctor if

    • symptoms persist.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    adults & children 6 years & older (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 24 hours.
    children 2 to under 6 yearsask a doctor
    children under 2 yearsdo not use

  • Other information

    • do not exceed 25ºC
  • Inactive ingredients

    benzalkonium chloride, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, propylene glycol, purified water, sodium citrate

  • Questions?

    1-800-873-8276

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: Carton sealed for your protection.

  • SPL UNCLASSIFIED SECTION

    MADE IN GERMANY

    DIST. BY PROCTER & GAMBLE,

    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

    VICKS ®

    Sinex™

    SEVERE

    Oxymetazoline HCl Nasal Decongestant


    ORIGNAL

    NASAL SPRAY

    • Fast Sinus Congestion & Pressure Relief
    • Powerful Vicks Vapors

    12
    HOUR

    ½ FL OZ
    (15 ml)

    SSS

  • INGREDIENTS AND APPEARANCE
    VICKS SINEX  SEVERE ORIGINAL
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64336-170
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.0005095 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64336-170-011 in 1 CARTON12/20/2018
    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 DrugM01212/20/2018
    Labeler - Procter & Gamble Manufacturing GmbH (333608813)
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