{"adverse_reactions":["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."],"description":["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."],"dosage_and_administration":["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."],"dosage_and_administration_table":["<table width=\"100%\"><caption/><tbody><tr><td> To make Epinephrine Chloride Solution</td><td>Epinephrine Chloride Solution 1 mg/mL</td><td>Isotonic Salt Solution</td></tr><tr><td> 0.5 mg/mL</td><td> 1 mL</td><td> 1 mL</td></tr><tr><td> 0.2 mg/mL</td><td> 1 mL</td><td> 4 mL</td></tr><tr><td> 0.1 mg/mL</td><td> 1 mL</td><td> 9 mL</td></tr></tbody></table>"],"effective_time":"20250414","how_supplied":["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"],"id":"f14f4f53-d409-4833-9e43-b0ad2e635a46","indications_and_usage":["1 INDICATIONS AND USAGE For use as a nasal decongestant. Apply locally as drops or spray, or with a sterile swab, as required."],"openfda":{},"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 Label: Epinephrine Chloride Solution (Epinephrine Nasal Solution,USP) 10 mg/10 mL (1 mg/mL) Vasoconstrictor for Topical Application 10 mL Vial Carton Label"],"set_id":"d2243a23-7856-45f5-8c85-e840b9c00ff1","spl_product_data_elements":["Epinephrine Chloride Solution Epinephrine Nasal Solution EPINEPHRINE HYDROCHLORIDE EPINEPHRINE ISOTONIC SODIUM CHLORIDE SOLUTION SODIUM METABISULFITE CHLOROBUTANOL"],"version":"6","warnings_and_cautions":["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."]}