Unisom labeling
This article was originally published in The Tan Sheet
Executive Summary
Updates to "Drug Facts" labeling for Pfizer's OTC sleep aid cleared by FDA June 3 through supplemental NDAs 18-066/S-011 and S-013. Changes provide for "new labeling for two additional package sizes (40- and 64-count) and revised labeling for four package sizes (8-, 16-, 32- and 48-count)," agency's approval letter states...