1. Pink Sheet

Rulemaking Needed For Acetaminophen Skin-Reaction Label Warning – CHPA

 
• By Eileen Francis

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encourages FDA to conduct a rulemaking to require label changes for acetaminophen OTCs the agency is suggesting in a draft guidance.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Label changes FDA suggests in a draft guidance to warn for skin reactions in acetaminophen-containing products should be proposed in a rulemaking to change the OTC monograph, the Consumer Healthcare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.

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