FDA Issues Guidance on Products that Contain Acetaminophen

FDA has issued guidance that provides the agency’s position on the inclusion of liver warnings on over-the-counter internal analgesic, antipyretic, and antirheumatic (IAAA) drug products that contain acetaminophen that differ from what is required in 21 Code of Federal Regulations (CFR) 201.326(a)(1)(iii)(A) and 21 CFR 201.326(a)(1)(v)(A)).

The guidance states that FDA will not object to the following warning label for OTC IAAA products containing acetaminophen “for adults only or labeled for adults and children under 12 years of age and [if] its directions for use result in a maximum daily dose of acetaminophen for the product that is less than 4000 mg for adults…, in place of the first bullet of the liver warnings required by § 201.326(a)(1)(iii)(A) and § 201.326(a)(1)(v)(A), respectively:

“Adults Only:

"Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take Ÿ more than 4000 mg of acetaminophen in 24 hours Ÿ with other drugs containing acetaminophen Ÿ 3 or more alcoholic drinks every day while using this product.

“Adults and children under 12 years of age:

"Liver warning: This product contains acetaminophen. Severe liver damage may occur if Ÿ adult takes more than 4000 mg of acetaminophen in 24 hours Ÿ child takes more than 5 doses in 24 hours Ÿ taken with other drugs containing acetaminophen Ÿ adult has 3 or more alcoholic drinks every day while using this product.”

The guidance also states that “OTC IAAA products containing acetaminophen that are labeled only for children under 12 years of age must continue to include in their labeling the liver warning required under § 201.326(a)(1)(iv) and described below:

“Children under 12 years of age:

“Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: Ÿ more than 5 doses in 24 hours, which is the maximum daily amount [optional: ‘for this product’] Ÿ with other drugs containing acetaminophen.”

Source: FDA