Nonprescription Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee

On April 4, 2017, the Nonprescription Drugs Advisory Committee (NDAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) did not support, by a vote of 5-Yes to 15-No, with no abstentions, that the combination of an analgesic with an antacid is a rational combination for the over-the-counter (OTC) use to relieve minor aches and pains associated with heartburn, sour stomach, acid indigestion, fullness, belching, gas, or nausea. The Committees also expressed concerns with the hangover indication of several OTC monographs.