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Sodium phosphate OTCs

This article was originally published in The Tan Sheet

Executive Summary

Labels for rectal products containing sodium phosphate/sodium biphosphate will be required to bear sodium content and warnings, according to a final rule published in the Federal Register Nov. 29. Users with certain medical conditions are at risk for an electrolyte imbalance, and high levels of sodium from "both active and inactive ingredients" in the drugs have been implicated in serious adverse events and deaths, FDA notes. The final reg is not expected to have a significant economic impact as it requires "minor relabeling" of fewer than 300 SKUs. No comments were submitted on the proposed rule released in March (1"The Tan Sheet" March 29, 2004, In Brief)...

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