Family Care Childrens Decongestant Nose Drops
FDA Label NDC 65923-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp for the product Family Care Childrens Decongestant Nose Drops (NDC 65923-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                         Purpose

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

Otc - 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

Otc - Ask Doctor

Ask a doctor before use if the child has

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

Otc - 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

Otc - 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.

Otc - 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

Package Label.Principal Display Panel

Image Of Carton Label (Fcchildrensdeconnosedrop)

Image Of Carton Label (Fcchildrensdeconnosedrop)

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