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FDA Limits Acetaminophen Dosage in Prescription Drugs

By Saunders Law Group on January 31, 2014


Although acetaminophen has been a common staple of household medicine cabinets for nearly six decades, concerns about the drug’s safety still persist. For many years, the medical community has recognized several serious side effects from exceeding the recommended daily dose of acetaminophen. But as combination drugs containing acetaminophen become increasingly common, it’s easier than many people think to reach maximum dosage levels. In fact, the National Institutes of Health reports that acetaminophen overdose is one of the most common causes of poisoning worldwide.

For that reason, the FDA has officially issued a dosage limit for all prescription drugs containing acetaminophen. A popular ingredient in combination painkillers, acetaminophen is found in Percocet, Vicodin, Lortab, Tylenol with Codeine and Oxycodone just to name a few. According to several studies cited by the FDA, acetaminophen doses over 325mg do not add enough pain relieving benefits to outweigh the potential health risks, which include severe skin reactions, liver damage and even death. Drug manufacturers received a warning from the FDA in 2011 that the 325 mg limit would go into effect in January 2014, but thus far, only about half have complied.

So, what’s at stake for medical professionals? If a doctor or other medical professional prescribes you a combination drug but fails to warn you about the risks of taking too much acetaminophen, it may be possible to hold them liable for their negligence. It is their responsibility to take a thorough medical history and consider any possible medications that could be in conflict. When you receive a prescription from your doctor, make sure that you’re adequately informed. You might not realize that the over-the-counter Tylenol you’re taking to supplement your painkillers is putting you over the recommended maximum dose. For an adult, the maximum dose is 4,000 mg/day.

The warning issued by the FDA last week only applies to combination drugs, but the agency is expected to release subsequent recommendations for over-the-counter drugs as well.

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