FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS- phenylephrine hydrochloride solution

FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS by

Drug Labeling and Warnings

FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS by is a Otc medication manufactured, distributed, or labeled by UNITED EXCHANGE CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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)