WASHINGTON, (NBC) - The FDA is trying to make sure you don't overdose on Acetaminophen and suffer serious liver damage, or even death.
You may not recognize the drug's name but you're probably familiar with many of the common over the counter products that contain it: Tylenol, Nyquil, Theraflu and more.
Officials emphasize that Acetaminophen is a safe and effective drug when used properly. The problem is, many don't know they're taking it, so they combine medications and end up ingesting lots more of the drug than is safe.
FDA advisors voted to lower both the daily maximum and single doses of Acetaminophen in painkillers and cold medicines. "Our concern is that we maintain a dose availability that's going to be effective to treat minor aches and pains that consumers are seeking," said Sandra Kweder of the FDA Office of New Drugs.
The panel stopped short of pulling over the counter meds off the market but did recommend pulling prescription painkillers like Vicodin and Percocet that combine Acetaminophen with stronger narcotics.
Taking too much of these medicines, or combining them, can cause serious, even fatal, liver disease. Every year, 200 Americans die and 56,000 end up in the hospital, from overdosing many of them, accidental.
Rebecca Drake, a pharmacist, had no idea her sister April was taking so much Tylenol for stomach pain. April's liver failed. She died.
"We're not sure how much she ended up taking but it wasn't helping so she kept increasing her dose thinking, you know, more is better," said Drake.
But because Acetaminophen is a safe and effective drug when used properly, manufacturers and consumers with chronic pain want to make sure it's widely available. If the FDA follows its experts' advice, higher doses, now over the counter, would be available by prescription only.
"I'm concerned about the consumer who can't get to the doctor to get a prescription, who has used the acetaminophen as a standard way of treating their chronic pain," said Linda Suydam with the Consumer Healthcare Products Association.
FDA advisors are also considering whether to require smaller packages or a stronger label.