The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
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 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
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 54288-123-01This 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, LLCLargo, FL 33773.Rev: 08/2020LI123C-01R-2005
Principal Display Pannel
Manufactured by:BPI Labs, LLCLargo, FL 33773.Rev: 08/2020LI123C-01R-2005
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