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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In a July 3 draft guidance, the agency says it will allow some acetaminophen products to warn that “severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours

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• By Eileen Francis

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More from North America

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

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• By Derrick Gingery

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• By Malcolm Spicer

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