Skip to Content

Epinephrine Nasal Solution

Generic Name: epinephrine hydrochloride
Dosage Form: nasal solution

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.

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 LABEL Item Code (Source) NDC:54288-123
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE HYDROCHLORIDE (EPINEPHRINE) EPINEPHRINE HYDROCHLORIDE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOTONIC SODIUM CHLORIDE SOLUTION
SODIUM METABISULFITE
CHLOROBUTANOL
Packaging
# Item Code Package Description
1 NDC:54288-123-01 10 mL in 1 BOX
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 Operations
BPI Labs, LLC 078627620 manufacture(54288-123), label(54288-123)
BPI Labs, LLC