FDA Issues Draft Guidance on Labeling of OTC Acetaminophen Products

The Food and Drug Administration (FDA) has issued draft guidance for makers of over-the-counter (OTC) acetaminophen drugs, providing alternative language to the liver warning section in the labeling.

In certain instances, the FDA will allow drugmakers to state the maximum daily dosage as 4,000 mg in a 24-hour period for the liver warning. This language can be used instead of specifying the maximum number of tablets or dosage units for the product, as has been required, according to an FDA press release.

In 2009, the FDA published a final rule requiring that OTC products with acetaminophen include a warning stating that exceeding the maximum daily amount of acetaminophen (4,000 mg) is associated with severe liver damage. Currently, manufacturers must use specific language referring to the product’s maximum dosage in terms of the total number of pills or tablets that should not be exceeded in a 24-hour period.

The agency said that some labels for OTC products with acetaminophen show that the maximum daily dosage is less than 4,000 mg, which falsely suggests to consumers that they would suffer liver damage at a much lower dosage. The new language will allow drugmakers to have another option to properly characterize the risk of the liver warning requirement and ensure the appropriate dosing of these products.

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