FDA Proposes Changes to Over-the-Counter Cough-Cold Combination Drug Products

Summary

The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter cough-cold combination drug products to remove the combination of an oral bronchodilator and an expectorant, and to reclassify this combination drug product as Category II. The FDA is also proposing to classify the combination of an oral bronchodilator and an oral nasal decongestant as Category II, following data and information on the appropriateness of these combination drug products to treat mild asthma.