Epinephrine Chloride Solution

Manufacturer
BPI Labs, LLC
Effective date
2025-03-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:40:33

Label at a glance#

ProductEpinephrine Chloride Solution
Active ingredientEPINEPHRINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

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

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.

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...

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

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

3 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

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

DESCRIPTION SECTION

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

ADVERSE REACTIONS SECTION

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

HOW SUPPLIED SECTION

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

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

CartonCarton

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

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54288-12354288-123-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f14f4f53-d409-4833-9e43-b0ad2e635a46d2243a23-7856-45f5-8c85-e840b9c00ff12025-04-14Warnings, Adverse reactionsExact identifier
spl set id: d2243a23-7856-45f5-8c85-e840b9c00ff1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.