Rulemaking Needed For Acetaminophen Skin-Reaction Label Warning – CHPA

The Consumer Healthcare Products Association encourages FDA to conduct a rulemaking to require label changes for acetaminophen OTCs the agency is suggesting in a draft guidance. The trade group also asks for clarity in the order warnings are placed on product labels.

Label changes FDA suggests in a draft guidance to warn for skin reactions in acetaminophen-containing products should be proposed in a rulemaking to change the OTC monograph, the Consumer Healthcare Products Association says.

The trade group’s suggested process would mean that OTC acetaminophen product marketers would not be compelled to add label warnings for skin reactions until after a likely months- to years-long

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