OTC sodium phosphates laxative package size limited to 90 mL in FDA final rule.
This article was originally published in The Tan Sheet
Executive Summary
OTC SODIUM PHOSPHATES LAXATIVE PACKAGE SIZE LIMITED to no greater than 90 mL, or 3 oz., due to reports of deaths linked to inadvertent overdoses of product from larger-sized containers, FDA says in a final rule published in the May 21 Federal Register. The products currently are marketed in 45 mL and 90 mL bottles; the manufacturer of the only major product sold in a larger size already has withdrawn the product from the market.