FDA Label for Norepinephrine Bitartrate
View Indications, Usage & Precautions
Norepinephrine Bitartrate Product Label
The following document was submitted to the FDA by the labeler of this product Cantrell Drug Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
• Warnings And Precautions
Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.
• Adverse Events
To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.
• How Supplied
Norepinephrine bitartrate injection solution is supplied as a sterile, nonpyrogenic solution that is clear, colorless at 250 mL in a Single-Dose Injection Solution Bag.
This product is Preservative-Free and Latex-Free.
• Ingredients
Each 1 mL contains the equivalent of 64 mcg norepinephrine base, 50 mg dextrose, 473.6 mcg sodium chloride, 128 mcg sodium metabisulfite, and pH adjusters include hydrochloric acid and/or sodium hydroxide, if necessary.
• Storage And Handling
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.
Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
• Dosage And Administration.
FOR INTRAVENOUS USE ONLY. PRESERVATIVE-FREE INJECTION SOLUTION.
* Please review the disclaimer below.