• Warnings And Precautions
Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.
Heparin Sodium
FDA Label NDC 52533-179
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cantrell Drug Company for the product Heparin Sodium (NDC 52533-179). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding • warnings and precautions, • adverse events, • how supplied, • ingredients, • storage and handling, • dosage and administration., rx only, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
• Adverse Events
To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.
• How Supplied
Contains 25,000 USP Units of Heparin Sodium in 0.45% Sodium Chloride in a 250 mL Single-Dose Bag. Volume & Concentration exlude additive & manufacturer overfill.
This product is Sterile, Nonpyrogenic, and Latex Free.
• Ingredients
Each 1 mL contains contains Heparin Sodium 100 USP Units, Sodium Chloride 4.5 mg, Benzyl Alcohol 0.0002 mL. May contain Hydrochloric Acid and/or Sodium Hydroxide for pH adjustment.
• Storage And Handling
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
• Dosage And Administration.
FOR INTRAVENOUS USE.
Rx Only
Rev. 05/15
CANTRELL DRUG COMPANY
LITTLE ROCK, AR 72207
* Please review the disclaimer below.
