FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

FDA has issued a draft guidance on the labeling of over-the-counter (OTC) products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.

The current guidelines require manufacturers of OTC products that contain acetaminophen to include a specific warning on the label that exceeding the maximum daily amount of acetaminophen could cause liver damage. The current language refers to the product’s maximum dosage in terms of dosage units or total amount of tablets in a 24-hour period.

The new draft guidance would give manufacturers the option of stating the maximum daily dosage as 4000 mg. The new language states: “Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.”

According to the draft guidance, FDA “believes that this alternative language should eliminate the potential confusion…and help ensure appropriate dosing of OTC acetaminophen-containing products, while also informing consumers that using more than the currently proposed maximum daily dose of 4000 mg of acetaminophen may result in severe liver damage.”