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Revised Alcohol Warning on Tylenol®.

  On July 8, McNeil Consumer Products, marketer of Tylenol®, announced that its redesigned label will include a revised alcohol warning statement by late July. As proposed by FDA in November, the new warning will read: "If you drink three or more alcoholic beverages every day, ask your doctor if you should take Tylenol® or other pain relievers. Chronic heavy alcohol users may be at increased risk of liver damage when taking more than the recommended dose (overdose) of Tylenol®." This statement differs from the FDA's proposed warning which linked any dosage of Tylenol® combined with alcohol use to possible organ damage. The revised warning will appear on adult regular Tylenol® and Extra Strength Tylenol®, but not the extended-release form of Tylenol®. An alcohol warning related to increased risk of stomach bleeding will also appear on Motrin IB®, the ibuprofin product McNeil acquired from Pharmacia & Upjohn last year. McNeil is the first manufacturer to adopt the organ-specific alcohol warning proposed by FDA.  

F-D-C Reports--"The Tan Sheet" July 13, 1998.

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