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Vicks Sinex (The Procter & Gamble Manufacturing Company)

Available Formats

Dosage Form Package Information Links
SPRAY 1 BOTTLE, PUMP in 1 CARTON (37000-801-01) > 15 mL in 1 BOTTLE, PUMP Label Information

Complete Vicks Sinex Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Oxymetazoline HCl 0.05%


  • Purpose

    Nasal decongestant


  • Uses

    temporarily relieves nasal congestion due to

    • colds
    • hay fever
    • upper respiratory allergies

  • 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 this product
    • do not exceed recommended dosage
    • use of this container by more than one person may spread infection
    • temporary burning, stinging, sneezing, or increased 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.


  • 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

    • store at room temperature

  • Inactive ingredients

    acesulfame potassium, aloe vera, benzalkonium chloride, chlorhexidine gluconate, citric acid, disodium EDTA, fragrance, purified water, sodium citrate, sodium hydroxide, sorbitol, tyloxapol


  • Questions?

    1-800-873-8276


  • SPL UNCLASSIFIED SECTION

    www.vicks.com
    Made in Germany
    Dist. by Procter & Gamble,
    Cincinnati OH 45202.


  • PRINCIPAL DISPLAY PANEL - 15 ml Carton

    VICKS ®

    Sinex ®

    12 HOUR
    DECONGESTANT
    ULTRA FINE MIST

    Oxymetazoline HCl...
    Nasal Decongestant

    MOISTURIZING

    Cold & Allergy
    Congestion

    Sinus Pressure

    12
    HOUR
    RELIEF

    Fast Acting
    Day/Night Relief

    See Drug Facts

    1/2 FL OZ
    (15 ml)

    Principal Display Panel - 15 ml Carton

  • INGREDIENTS AND APPEARANCE
    VICKS SINEX  12 HOUR DECONGESTANT ULTRA FINE MIST MOISTURIZING
    oxymetazoline hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-801
    Route of Administration NASAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.000512 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    TYLOXAPOL (UNII: Y27PUL9H56)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-801-01 1 in 1 CARTON 07/06/2010 10/15/2018
    1 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/06/2010 10/15/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)