Alcohol warning for ibuprofen citing stomach "upset" suggested by Whitehall.
This article was originally published in The Tan Sheet
Executive Summary
ALCOHOL WARNING FOR IBUPROFEN PRODUCTS CITING STOMACH "UPSET" suggested by Whitehall-Robins in Jan. 27 comments to FDA as an alternative to a label warning citing possible stomach "bleeding." An OTC ibuprofen warning referring to stomach bleeding is "arbitrary when substantive data show no increased risk of bleeding," the Advil marketer argues. Therefore, "if an alcohol warning were to be required on OTC ibuprofen products, a far more appropriate warning would be: `[product name] may increase your risk of stomach upset,'" the company states.