Label: EPINEPHRINE CHLORIDE SOLUTION- epinephrine nasal solution solution
- NDC Code(s): 54288-123-01
- Packager: BPI Labs, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 12, 2024
If you are a consumer or patient please visit this version.
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- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
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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.
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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
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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
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INGREDIENTS AND APPEARANCE
EPINEPHRINE CHLORIDE SOLUTION
epinephrine nasal solution solutionProduct 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)
