OTC Acetaminophen Label Guidance For Liver Warning Clarifies Ingredient Specifics

FDA allows marketers of acetaminophen-containing OTC products to use an alternative liver warning, according to an updated guidance. The change from the draft, which aligns with a request by CHPA, separates maximum dosage for the ingredient from the dosage included in a certain product.

Differentiating on OTC drug labels that 4,000mg is the maximum daily dosage for acetaminophen but is not the amount of the ingredient in a product complies with a requirement to warn on the risk of liver injury, according to an updated FDA guidance.

OTC drug labels that differentiate the 4,000mg maximum daily dosage for acetaminophen from the amount of the ingredient in a...

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