EPINEPHRINE CHLORIDE SOLUTION- epinephrine nasal solution solution

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]

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

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

Note: Do not use the solution if it is pinkish or darker than yellow or if it contains a precipitate.

3 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.

4 DESCRIPTION

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.

5 ADVERSE REACTIONS

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

6 HOW SUPPLIED/STORAGE AND HANDLING

Each carton contains one vial of 10 mg/10 mL (1 mg/mL)  of Epinephrine Chloride Solution (Epinephrine Nasal Solution,USP) in an amber glass vial.

NDC: 54288-123-01         10 mL Vial

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

12393 Belcher Rd S, Suite 450

Largo, FL 33773

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Carton:
Epinephrine Chloride Solution
(Epinephrine Nasal Solution, USP)
10 mg/10 mL (1 mg/mL)
Vasoconstrictor for Topical Application
10 mL Vial

Label:
Epinephrine Chloride Solution
(Epinephrine Nasal Solution,USP)
10 mg/10 mL (1 mg/mL)
Vasoconstrictor for Topical Application
10 mL Vial

INGREDIENTS AND APPEARANCE

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

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

Labeler - BPI Labs, LLC (078627620)

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