Label: VICKS SINEX 12 HOUR DECONGESTANT ULTRA FINE MIST- oxymetazoline hydrochloride spray

  • NDC Code(s): 64336-171-01, 64336-171-02
  • 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
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlarged prostate gland

    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 and ask a doctor if

    • symptoms persist.

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

    Keep out of reach of children.

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

  • Directions

    Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.

    adults & children 6 yrs. & 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 yrs.ask a doctor
    children under 2 yrs.do not use
  • Other information

    • do not exceed 25°C
  • Inactive ingredients

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

  • Questions?

    1-800-873-8276

  • SPL UNCLASSIFIED SECTION

    Only selected information is listed on the bottle label. Keep this carton for future reference.

    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

    ORIGINAL

    Ultra Fine Mist

    • Fast Sinus Congestion & Pressure Relief
    • Powerful Vicks Vapors

    12
    HOUR

    ½ FL OZ
    (15 ml)

    171

  • INGREDIENTS AND APPEARANCE
    VICKS SINEX  12 HOUR DECONGESTANT ULTRA FINE MIST
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64336-171
    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
    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)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64336-171-011 in 1 CARTON04/27/2015
    115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:64336-171-022 in 1 CARTON04/27/2015
    215 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/27/2015
    Labeler - Procter & Gamble Manufacturing GmbH, (333608813)
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