PENNEX "COMPARE TO BENADRYL" LABEL CLAIM FOUND "UNACCEPTABLE" BY FDA
This article was originally published in The Tan Sheet
Executive Summary
PENNEX "COMPARE TO BENADRYL" LABEL CLAIM FOUND "UNACCEPTABLE" BY FDA because it "implies that the product is identical to the referenced brand name in all respects, including inactive ingredients, etc.," the agency said in a July 25 warning letter to the company. The label for Pennex' private-label Complete Allergy Medicine tablets (25 mg diphenhydramine) bears the statement: "Compare to Benadryl."