ADVERSE REACTIONS SECTION.
o ADVERSE EVENTS. To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.
DOSAGE & ADMINISTRATION SECTION.
o DOSAGE AND ADMINISTRATION.. FOR INTRAVENOUS USE ONLY. PRESERVATIVE-FREE INJECTION SOLUTION.
DOSAGE FORMS & STRENGTHS SECTION.
o INGREDIENTS. Each 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.
HOW SUPPLIED SECTION.
o HOW SUPPLIED. Norepinephrine bitartrate injection solution is supplied as sterile, nonpyrogenic solution that is clear, colorless at 250 mL in Single-Dose Injection Solution Bag.This product is Preservative-Free and Latex-Free.
SPL UNCLASSIFIED SECTION.
Rx OnlyRev. 03/15CANTRELL DRUG COMPANYLITTLE ROCK, AR 72207.
STORAGE AND HANDLING SECTION.
o STORAGE AND HANDLING. Store at 20 to 25C (68 to 77F). [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 precipitate.
WARNINGS AND PRECAUTIONS SECTION.
o WARNINGS AND PRECAUTIONS. Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.