OTC labeling
This article was originally published in The Tan Sheet
Executive Summary
Generic labeling mock-ups for cimetidine 200 mg tablets, loperamide HCl (1 mg oral solution and 2 mg chewable tablets) and acetaminophen suppositories (120 mg, 325 mg and 650 mg) posted on FDA's OTC Web site (www.fda.gov/cder/otc). Reference labels are second wave published by agency to enable private labelers to implement OTC labeling final rule before reference listed drug holders change their labeling. First set of mock-ups was released in February; naproxen sodium tablets and miconazole vaginal cream labeling expected soon (1"The Tan Sheet" Feb. 26, p. 4)