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FDA Clarifies Label Warning For Acetaminophen Liver Damage

 
• By Elizabeth Crawford

The agency seeks to clarify potential confusion for consumers linked to label statements about the level of acetaminophen that can pose a threat. FDA proposes an alternative warning to be used on labels of some acetaminophen-containing products.

FDA proposes an alternative statement for OTC drug makers to use in a required label warning for acetaminophen-containing products to explain when the ingredient can cause severe liver damage.

In a July 3 draft guidance, the agency says it will allow some acetaminophen products to warn that...

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More from North America

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