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The U.S. Food and Drug Administration (FDA) today issued draft guidance to manufacturers of over-the-counter (OTC) acetaminophen products, providing alternative language to the liver warning section of the product’s labeling.
In certain instances, FDA now will allow manufacturers to state the maximum daily dosage as 4,000 mg in a 24-hour period for the liver warning. This language can be used instead of specifying the maximum number of tablets or dosage units for the product, as has been required.
For more information please visit: Labeling for Products that Contain Acetaminophen
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