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WASHINGTON — The Food and Drug Administration has, for years, limited the amount of acetaminophen in any prescription painkiller to 325 milligrams a dose. Yet walk into your local CVS and you’ll still find dozens of non-prescription painkillers containing 500, even 650, milligrams of the ingredient.

The FDA also requires prescription codeine products to include a warning that they are unsafe for kids under 12. If your local drugstore carries it, you may find non-prescription codeine cough syrups that still list dosing information specifically for children.

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    • Judy, this is an excellent point! Some states have banned sales of over-the-counter codeine cough syrups, but others allow them to be sold as long as a person signs for them with the pharmacist (sometimes referred to as “behind-the-counter” drugs).

  • To say nothing of the different marketing environments for Rx and OTCs! FDA oversees the RX ads, but the Federal Trade Commission oversees OTCs. My research has shown that OTC ads have more misleading information, more emotional appeals and less information. I hope we can address some of these gaps in drug marketing regulations with this OTC bill going through congress.

  • I take a 650 mg x 2 APAP as needed. It’s an 8-hour time release product. It helps me sleep through the night. Any reason why this should not be on the market? I don’t think so!!

    The point of the combo with opioid regulation was to keep patients from taking too much APAP (>4 g/day is harmful to the liver).

    I hope we don’t throw out the baby with the bathwater.

    • Just to let you know Karl Tylenol is posion at doses of even 1500 milligrams and to even suggest this article is harming innovation into medicine that people buy everyday is triffling if u take Tylenol and it helps you then fine but some people it doesn’t help including people with fatty livers.

      Personally I would also like to see hospitals stop marketing this stuff.

      I have story’s of friends who died from too much APAP and I will continue to fight in thier name.

    • As a cancer patient, I am not allowed to take any NSAID. APAP is my only choice. And 1300 mg is in the “safe” range, even at 3 doses per day. Something must remain available for me and for others like me.

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