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Wake-up call over Tylenol PM

<p><b>WASHINGTON.</b> Tylenol PM and other widely used acetaminophen pain drugs that include a sleep-aid failed to show significant benefit in a key study, U.S. health regulators have told drugmakers 15 years after the industry submitted the data.</p>

WASHINGTON. Tylenol PM and other widely used acetaminophen pain drugs that include a sleep-aid failed to show significant benefit in a key study, U.S. health regulators have told drugmakers 15 years after the industry submitted the data.


Patients taking the drugs did not fall asleep significantly faster than those who took only acetaminophen or the sedative, known as diphenhydramine citrate, the FDA said in a letter to the industry earlier this year.


The letter comes amid closer scrutiny of dozens of other Tylenol products for children recalled last Friday after FDA inspection turned up contaminated ingredients and unsanitary conditions.

 
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