Label: CAREONE COLD AND SINUS- phenylephrine hydrochloride solution/ drops

  • NDC Code(s): 41520-831-10
  • Packager: American Sales Company
  • 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 September 13, 2018

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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 the active ingredient in Neo-Synephrine® Extra Strength

    COLD & SINUS NOSE DROPS

    Phenylephrine HCl 1.0%

    Nasal Decongestant

    4hr

    Extra Strength

    Easy To Use & Dispense

    Relieves:

    Nasal Congestion

    Sinus Congestion

    Sinus Pressure

    Non-drowsy

    Gluten Free

    OUR PHARMACISTS RECOMMEND

    1 FL OZ (30mL)

    cold-and-sinus-nose-drops-image
  • INGREDIENTS AND APPEARANCE
    CAREONE COLD AND SINUS 
    phenylephrine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-831
    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 (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorYELLOW (Clear to slightly yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-831-101 in 1 CARTON10/20/2016
    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 finalpart34110/20/2016
    Labeler - American Sales Company (809183973)
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