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Alka-Seltzer Plus needs more time to re-label

This article was originally published in The Tan Sheet

Executive Summary

Bayer HealthCare asks FDA for more time to change packaging for its cold and flu relief line to comply with a final rule for labeling acetaminophen products. Thirteen stock-keeping units under the Alka-Seltzer Plus brand will be unable to accommodate organ-specific warnings by the rule's effective date of April 29, Bayer says in a Feb. 16 1letter to the agency. The firm's VP of Regulatory Affairs Leonard Baum explains, "Bayer was forced to wait" for FDA's technical amendment of Nov. 25, 2009, which clarified that smaller immediate containers such as blister cards and sachets must bear liver injury and stomach bleeding warnings (2"The Tan Sheet" Nov. 30, 2009). Bayer asks for a 12-month deferral to re-label ASP foil pouches and stick packs, and a six-month deferral to re-label the companion cartons. A spokeswoman said the company has not yet heard from FDA

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