FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS

Dosage form: solution
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 1.25mg in 1mL
Labeler: UNITED EXCHANGE CORP
NDC Code: 65923-005

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 Facts

Active ingredient                                                         Purpose

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

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

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

Ask a doctor before use if the child has

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

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

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

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 ingredients

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

Distributed by:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

MADE IN KOREA

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FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS 
phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-005
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE1.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POTASSIUM PHOSPHATE, MONOBASIC 
WATER 
Packaging
#Item CodePackage Description
1NDC:65923-005-541 BOTTLE, DROPPER (BOTTLE) 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)

Revised: 01/2012
 
UNITED EXCHANGE CORP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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