Pain :: Label changes for products containing acetaminophen

To help ensure safe use of OTC products, and to provide consumers with the labeling necessary for them to make more informed medical decisions, FDA is proposing the following label changes for products containing acetaminophen:

To require new warnings which would highlight the potential for liver toxicity, particularly when using acetaminophen in high doses, when taking more than one product with acetaminophen, and when taken with moderate amounts of alcohol;

To require that the ingredient acetaminophen be prominently identified on the product’s principal display panel (PDP) of the immediate container, and the outer carton (if applicable).

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