Label: NASAL- oxymetazoline hydrochloride spray

  • NDC Code(s): 41250-989-10
  • Packager: Meijer Distribution Inc
  • 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 26, 2018

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  • 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 an 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 an increase in 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 (1-800-222-1222).

  • Directions

    Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. 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. Secure cap after use.

    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 20-25°C (68-77°F)
  • Inactive ingredients

    benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

  • Questions or comments?

    1-800-719-9260

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Compare to Vicks® Sinex® Severe active ingredient

    #1 DOCTOR RECOMMENDED ADULT NASAL SPRAY ACTIVE INGREDIENT

    MAXIMUM STRENGTH

    nasal spray

    oxymetazoline HCl Nasal Decongestant

    SEVERE

    12 HOUR RELIEF

    Ultra Fine Mist with Menthol

    Sinus Congestion & Pressure

    Fast & Powerful Relief

    1 FL OZ (30 mL)

    7x0-6e-nasal-spray.jpg
  • INGREDIENTS AND APPEARANCE
    NASAL 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-989
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    MENTHOL (UNII: L7T10EIP3A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-989-101 in 1 CARTON11/20/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/20/2018
    Labeler - Meijer Distribution Inc (006959555)
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