Although widely used, misuse can be harmful. FDA estimates that 56ꯠ emergency room visits and 100 deaths a year are due to acetaminophen overdose. FDA is urging consumers to read labels carefully and follow the directions.
FDA noted that in September 2002 its Non-Prescription Drugs Advisory Committee recommended labeling changes for certain OTC drugs, including acetaminophen and NSAIDs, to better inform consumers about the ingredients in the products and possible side effects from improper use. FDA said it will consider labeling changes and is reviewing changes that better reflect the latest scientific thinking.
