VICKS SINEX SEVERE NO DRIP (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [THE PROCTER & GAMBLE MANUFACTURING COMPANY]

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VICKS SINEX SEVERE NO DRIP (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 37000-527-01
Set ID 6f2b46cd-59c5-4196-e053-2991aa0a61cb
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class
Product Number
Application Number PART341
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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 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

    Shake well before use. 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 25C
  • 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?

    1-800-873-8276

  • SPL UNCLASSIFIED SECTION

    DIST.BYPROCTER&GAMBLE,
    CINCINNATIOH45202

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    VICKS ®

    Sinex™

    SEVERE

    Oxymetazoline HCl | Nasal Decongestant

    NO DRIP

    NASAL SPRAY

    • Fast Sinus Congestion & Pressure Relief
    • Powerful Vicks Vapors

    12
    HOUR

    ½ FL OZ (15 ml)

    SSND

  • INGREDIENTS AND APPEARANCE
    VICKS SINEX  SEVERE NO DRIP
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-527
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.0005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    MENTHOL (UNII: L7T10EIP3A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-527-011 in 1 CARTON07/10/2018
    115 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 finalpart34107/10/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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