FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [UNITED EXCHANGE CORP]

FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [UNITED EXCHANGE CORP]
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NDC 65923-005-54
Set ID 7a79b1e0-e019-4ab7-9445-c0348293c3ba
Category HUMAN OTC DRUG LABEL
Packager UNITED EXCHANGE CORP
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703 USA

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS 
    phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-005
    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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-005-541 in 1 BOX
    115 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/10/2012
    Labeler - UNITED EXCHANGE CORP (840130579)

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