Drug Labeling; Sodium Labeling for Over-the-Counter Drugs

The Food and Drug Administration (FDA) is amending the general labeling provisions for over-the-counter (OTC) drug products to require that the sodium content of all OTC drug products intended for oral ingestion be included in labeling when the product contains 5 milligrams (mg) or more sodium per a single dose; require that all OTC drug products intended for oral ingestion containing more than 140 mg sodium in the labeled maximum daily dose bear a general warning that persons who are on a sodium-restricted diet should not take the product unless directed by a doctor; and provide for the voluntary use of certain terms (``sodium free,'' ``very low sodium,'' and ``low sodium'') relating to an OTC drug product's sodium content per labeled maximum daily dose. FDA is issuing this final rule in order to provide uniform sodium content labeling for all OTC drug products intended for oral ingestion (whether marketed under an OTC drug monograph, an approved application, or no application), and to provide for the voluntary use in OTC drug labeling of the same terms used to describe sodium content in food labeling.