SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [MCKESSON]

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SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [MCKESSON]
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NDC 49348-197-27
Set ID ac576e56-97e3-4091-ad12-ed30c26a9a44
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient

    Phenylephrine hydrochloride 1.0%

  • Purpose

    Nasal decongestant

  • Uses

    •
    temporarily relieves nasal congestion due to:
    •
    common cold
    •
    hay fever
    •
    upper respiratory allergies
    •
    temporarily relieves sinus congestion and pressure
    •
    shrinks swollen membranes so you can breathe more freely
    •
    temporarily restores freer breathing through the nose
  • Warnings

  • Do not use

    if you have ever had an allergic reaction to this product or any of its ingredients

  • Ask a doctor before use if you have

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland
  • When using this product

    •
    do not use more than directed
    •
    do not use 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

    •
    use only as directed
    •
    adults and children 12 years of age and older: 2 or 3 drops in each nostril not more often than every 4 hours
    •
    children under 12 years of age: ask a doctor
  • Other information

    •
    store at 20-25°C (68-77°F)
    •
    Protect from light. Store in outer carton until contents used.
  • Inactive ingredients

    anhydrous citric acid, benzalkonium chloride solution, purified water, sodium chloride, sodium citrate

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    COMPARE TO NEO-SYNEPHRINE® EXTRA STRENGTH ACTIVE INGREDIENT

    nose drops

    Phenylephrine HCl 1.0%

    Nasal Decongestant

    Easy to use & dispense

    Fast relief from nasal congestion

    EXTRA STRENGTH

    GLUTEN FREE

    1 FL OZ (30 mL)

    nose drops image
  • INGREDIENTS AND APPEARANCE
    SUNMARK NOSE 
    phenylephrine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-197
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorYELLOW (Clear to slightly yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-197-271 in 1 CARTON08/21/2003
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/21/2003
    Labeler - Strategic Sourcing Services LLC (116956644)
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