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FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS (UNITED EXCHANGE CORP)

Available Formats

Dosage Form Package Information Links
SOLUTION 1 BOTTLE, DROPPER in 1 BOX (65923-005-54) > 15 mL in 1 BOTTLE, DROPPER Label Information

Complete FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:65923-005
    Route of Administration NASAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-005-54 1 in 1 BOX
    1 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/10/2012
    Labeler - UNITED EXCHANGE CORP (840130579)