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FDA requires additional labeling for several over-the-counter drugs

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The Food and Drug Administration said today that makers of over-the-counter pain relievers and fever reducers will be required to revise their labeling. Under the new rules, labels must include warnings about potential safety risks such as internal bleeding and liver damage associated with the use of these drugs.

Products included in the FDA’s decision include acetaminophen (such as Tylenol) and nonsteroidal anti-inflammatory drugs. Commonly known as NSAIDs, nonsteroidal anti-inflammatory drugs include aspirin (such as Bayer), ibuprofen (such as Advil) and naproxen (such as Aleve). The revised labeling applies to all over-the-counter pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines.

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In addition to prominently displaying the active ingredients of these drugs on the packages and bottles, new labeling must also warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

The new rule requires all manufacturers to relabel their products within one year.

-- Andrea Chang

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