CAREONE FAST ACTING NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]

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CAREONE FAST ACTING NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]
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NDC 41520-729-10
Set ID 95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5
Category HUMAN OTC DRUG LABEL
Packager American Sales Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient

    Phenylephrine hydrochloride 1%

  • Purpose

    Nasal decongestant

  • Uses

    •
    temporarily relieves nasal congestion due to:
    •
    common cold
    •
    hay fever
    •
    upper respiratory allergies
  • Warnings

    Ask a doctor before use if you have

    •
    heart disease
    •
    diabetes
    •
    thyroid disease
    •
    high blood pressure
    •
    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. Frequent or prolonged use may cause nasal congestion to come back or get worse.
    •
    use only as directed
    •
    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

    •
    adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
    •
    children under 12 years: ask a doctor
    •
    Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.
  • Other information

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

    benzalkonium chloride, benzyl alcohol, boric acid, purified water, sodium borate

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient in 4-Way® Fast Acting Nasal Spray

    FAST ACTING NASAL SPRAY

    Phenylephrine Hydrochloride 1 %

    Nasal Decongestant

    4hr

    Relieves:

    Nasal Congestion

    Swollen Nasal Membranes

    Sinus Congestion

    Sinus Pressure

    Gluten Free

    OUR PHARMACISTS RECOMMEND

    1 FL OZ (30mL)

    648D4OF-fast-acting-nasal-spray.jpg
  • INGREDIENTS AND APPEARANCE
    CAREONE FAST ACTING NASAL 
    phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-729
    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)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-729-101 in 1 CARTON11/30/2016
    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 finalpart34111/30/2016
    Labeler - American Sales Company (809183973)
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