Package Size Limitation for Sodium Phosphates Oral Solution and Warning and Direction Statements for Oral and Rectal Sodium Phosphates for Over-the-Counter Laxative Use

The Food and Drug Administration (FDA) is issuing a final rule to limit the container size for sodium phosphates oral solution (dibasic sodium phosphate/monobasic sodium phosphate oral solution) to not greater than 90 milliliters (mL) (3 ounces (oz)) when used as an over-the-counter (OTC) laxative drug product. FDA is limiting the container size because of reports of deaths associated with an overdosage of sodium phosphates oral solution when the product was packaged in a larger-size container and a larger than intended dose was ingested inadvertently. The agency is also requiring warning and direction statements to inform consumers that exceeding the recommended dose of oral and rectal sodium phosphates products in a 24-hour period can be harmful. This final rule is part of the ongoing review of OTC drug products conducted by FDA.