Sep 17, 2025
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The key ingredient that underpins many nasal decongestants don't work as promised when taken orally.
The key ingredient that underpins many nasal decongestants don't work as promised when taken orally. Following an evaluation of clinical trial data, a panel of expert advisors for the United States Food and Drug Administration (FDA) agrees oral phenylephrine-based (PE) drugs are no better at reducing stuffiness than a placebo. While still safe to ingest, too much of the medicine is broken down before it gets to the bloodstream to have any real effect, they say. The panel's recommendation, laid out in a briefing document published this week, is that the FDA reclassify oral PE decongestants so that they are not falsely labeled as effective. This could force manufacturers to reformulate products like Advil Sinus Congestion & Pain, Sudafed PE Nasal Decongestant, and Tylenol Cold & Flu Severe, among many, many others.
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An extensive review determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion.
The Food and Drug Administration on Thursday proposed ending the use of a common ingredient found in many popular over-the-counter cold and allergy medications. The agency said an extensive review of available data determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion. It comes more than a year after advisors to the FDA unanimously reached the same conclusion. Based on the data, “we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a release. The FDA said the proposed order is not based on safety concerns and not final yet, which means companies can still market over-the-counter drugs containing oral phenylephrine for now. But a final decision would force pharmacies to clear shelves of hundreds of products containing oral forms of the ingredient, which is found in versions of drugs such as NyQuil, Benadryl, Sudafed and Mucinex. Last year, CVS said it has already moved to pull certain medicines containing oral phenylephrine.
dealer: man i got some straight gas, this new strain is so good they gotta lock it up. it's called "sudafed"
me: whatever. i don't feel shit
10 minutes later: bro this air is so fresh it hurts. i think i can feel my brain freezing
my buddy hypertension, pacing: the phenylephrine is lying to us
With winter setting in around much of the country, many people are also gearing up for cough and cold season. But the Food and Drug Administration now says that phenylephrine, a long-used ingredient in many over-the-counter medicines, is ineffective and should be removed.
Update your medicine cabinets!
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Is it possible for your brain-blood barrier to get so fucked that Imodium becomes psychoactive?
"Long COVID is turning a common diarrhea treatment into a recreational drug - and three states are preparing to ban it. Find out more when we return" -- exciting new addition to a sequence of legislative/regulatory decisions that have sold millions of dollars worth of counterfeit decongestant without reducing addiction/OD rates at all.
I knew it, I fucking knew it! That stuff never worked, always went for the real pseudoephedrine
FDA says phenylephrine doesn't work
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