Label: CVS CHILDREN DECONGESTANT NOSE DROPS- phenylephrine hydrochloride solution

  • 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 July 12, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                                         Purpose

    Phenylephrine Hydrochloride USP 0.125%...................Nasal Decongestant

  • PURPOSE

    Uses

    • temporarily relieves nasal congestion, due to common cold, hay fever, or other upper respiratory allergies
    • helps clear nasal passages; shrinks swollen membranes
    • temporarily restores freer breathing through the nose
    • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
  • WARNINGS

    Warnings

    • do not exceed recommended dosage
    • do not use with any other products containing decongestants
  • ASK DOCTOR

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
  • WHEN USING

    When using this product temporary discomfort may occur such as:

    • burning
    • stinging
    • sneezing
    • increase in nasal discharge
    • the use of this dispenser by more than one person may spread infection
  • STOP USE

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms persist.  Do not use for more than 3 days.  Use only as directed.  Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions (Nasal use only)

    • children 2 to under 6 years (with adult supervision): 2 to 3 drops into each nostril, not more often than every 4 hours
    • children under 2 years of age: Consult a physician
  • STORAGE AND HANDLING

    Other information

    • do not use if solution is brown or contains a precipitate
    • protect from light
    • store at 20-25oC (68-77oF)
    • see bottle or box for lot number and expiration date
  • INACTIVE INGREDIENT

    Inactive ingredients

    Benzalkonium Chloride, Edetate Disodium, Glycerin, Polyethylene Glycol, Potassium Phosphate Monobasic, Purified Water, Sodium Phosphate Dibasic

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    CVS CHILDREN DECONGESTANT NOSE DROPS 
    phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-9930
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68169-9930-61 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/12/2010
    Labeler - TAI GUK PHARM. CO., LTD. (631101656)