EPINEPHrine Chloride Solution(Epinephrine Nasal Solution, USP)10mg/10mL (1 mg/mL)Vasoconstrictor For Topical ApplicationRx Only

Epinephrine Chloride Solution by

Drug Labeling and Warnings

Epinephrine Chloride Solution by is a Prescription medication manufactured, distributed, or labeled by BPI Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EPINEPHRINE CHLORIDE SOLUTION- epinephrine nasal solution solution 
BPI Labs, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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EPINEPHrine Chloride Solution
(Epinephrine Nasal Solution, USP)
10mg/10mL (1 mg/mL)
Vasoconstrictor For Topical Application
Rx Only

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 Solution	Epinephrine Chloride Solution 1 mg/mL	Isotonic 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

EPINEPHRINE CHLORIDE SOLUTION 
epinephrine nasal solution solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54288-123
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE HYDROCHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOTONIC SODIUM CHLORIDE SOLUTION (UNII: VR5Y7PDT5W)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CHLOROBUTANOL (UNII: HM4YQM8WRC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54288-123-01	10 mL in 1 BOX; Type 0: Not a Combination Product	09/30/2020	11/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/30/2020	11/19/2020

Labeler - BPI Labs, LLC (078627620)

Establishment
Name	Address	ID/FEI	Business Operations
BPI Labs, LLC		078627620	manufacture(54288-123) , label(54288-123)

Revised: 11/2020

Document Id: fa8f3ef9-d5a8-431d-8e6d-61c64f8590b1

34391-3

Set id: d2243a23-7856-45f5-8c85-e840b9c00ff1

Version: 2

Effective Time: 20201119