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McNeil labeling deferrals

This article was originally published in The Tan Sheet

Executive Summary

Firm receives six-month deferral from OTC labeling compliance date for 10-count vials of two Tylenol SKUs and two-count pouches of Motrin IB, Tylenol and Imodium products. In Dec. 21 letter, FDA says product labeling must comply with "Drug Facts" requirements by Nov. 16. J&J division originally sought eight-month deferral for vials to allow time for new wrap-around labeling. In November, McNeil requested additional six months to implement "booklet style" labeling on five pouch products (1"The Tan Sheet" Dec. 10, 2001, p. 3)...

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