McNeil Proposes Tylenol Label Change To Keep 1,000-MG Dose Available OTC
This article was originally published in The Tan Sheet
In a bid to keep 500-mg tablets and 1,000-mg doses of acetaminophen available over the counter, McNeil Consumer Healthcare argues revised dosing instructions would address the root cause of unintentional overdose without unduly restricting access to the popular painkiller
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McNeil Consumer Healthcare lowers the maximum daily dose indicated on labels of Extra Strength Tylenol, the first in a series of dosing changes for the firm’s acetaminophen-containing products.
GlaxoSmithKline generated clinical data supporting the greater pain-relief efficacy of 1,000 mg of acetaminophen over 500-mg and 650-mg doses, urging FDA to maintain OTC status for the high dose.
Requiring all acetaminophen product labels to include the drug name, not an abbreviation, will help assure consumers know when an OTC or Rx drug contains the ingredient, says an executive with the manufacturer of the market-leading Tylenol line