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Zdrowie i gospodarka · 29/11/2004

FDA Extends Sodium Labeling Requirement to Rectal Drug Products

The Food and Drug Administration (FDA) is issuing a final rule to amend the regulations for sodium labeling of over-the-counter (OTC) drug products, specifically rectal products containing sodium phosphates, due to the risk of electrolyte imbalance and serious adverse events associated with high sodium levels.

Source: Federal Register — Food and Drug AdministrationOpen original release →