An FDA final guidance recommends a skin allergy warning on OTC monograph acetaminophen products that the Consumer Healthcare Products Association contends should be made in more formal rulemaking, even though most of the products now marketed already include the language.
Guidance On Acetaminophen Allergy Warning Trails Industry's Change
Final US guidance adds CHPA's suggestion for an example for a warning on labeling for products containing both acetaminophen and aspirin, needed to highlight where “Allergy Alert” and “Liver Warning” statements are on those products' labels.
