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  5. Label Information: Epinephrine Chloride Solution

FDA Label for Epinephrine Chloride Solution

View Indications, Usage & Precautions

Table of Contents

    1. WARNINGS AND PRECAUTIONS
    2. INDCATION AND USE
    3. DOSAGE AND ADMINISTRATION
    4. ADVERSE REACTIONS SECTIONS
    5. HOW SUPPLIED SECTION
    6. PRINCIPAL DISPLAY PANNEL

Epinephrine Chloride Solution Product Label

The following document was submitted to the FDA by the labeler of this product Bpi Labs, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Warnings And Precautions



Caution: Administer with caution to elderly people. Do not use if high blood pressure, heart disease, diabetes, or thyroid disease is present unless directed by a physician. If prompt relief is not obtained, consult a physician. Administer to pediatric patients under six years of age only on the advice of a physician.


Indcation And Use



For use as a nasal decongestant.Apply locally as drops or spray, or with a sterile swab, as required.

Instructions for diluting

 To make Epinephrine Chloride SolutionEpinephrine Chloride Solution 1 mg/mLIsotonic Salt Solution
 0.5 mg/mL 1 mL 1 mL
 0.2 mg/mL 1 mL 4 mL
 0.1 mg/mL 1 mL 9 mL


Dosage And Administration



Each mL contains 1 mg Epinephrine as the hydrochloride, dissolved in isotonic sodium chloride solution with 0.5% chlorobutanol (chloroform derivative) as a preservative and not more than 0.05% sodium metabisulfite as an antioxidant.EPINEPHrine nasal solution, USP must not be brought into contact with oxidizing agents.The solution is also quickly decomposed by iron salts and alkalies.


Adverse Reactions Sections



To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs, LLC at 1-727-471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch


How Supplied Section



EPINEPhrine Chloride Solution 10mg/10ml (1mg/1ml) in 10ml vial.NDC 54288-123-01

This product is sterile until opened.

Keep this and all drugs out of the reach of children.

Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Do not refrigerate or freeze, Protect from light.

Do not use if cap seal is broken or missing.

Manufactured by:

BPI Labs, LLC

Largo, FL 33773.

Rev: 08/2020

LI123C-01

R-2005


Principal Display Pannel



Manufactured by:

BPI Labs, LLC

Largo, FL 33773.

Rev: 08/2020

LI123C-01

R-2005


* Please review the disclaimer below.