Researchers suggest FDA remove phenylephrine from the OTC drug monograph after their study found the ingredient, in doses up to 40mg every four hours, is no more effective than a placebo in alleviating nasal congestion from seasonal allergic rhinitis.
Study Stirs Doubts On Phenylephrine, Questions On Monograph Process
Researchers say “an optimal dose of PE that is safe and produces clinically significant decongestion is still unknown,” and advocates for removing phenylephrine from the OTC monograph say their study is the proof FDA requested.