FDA Limits Tylenol in Prescription Combination Products Due to Liver Damage

The FDA announced it is restricting the amount of Tylenol (acetaminophen) allowed in combination prescription drugs to 325 mgs. The move is prompted by warnings that acetaminophen can cause liver damage. OTC products are not affected. The FDA has set 325 mg per capsule or tablet as the safe level for prescription combination products. The FDA is causing labels to be placed on combination prescription pain relievers, warning of liver damage caused from high levels of acetaminophen.

"Acetaminophen, also called APAP, is a drug that relieves pain and fever and can be found in both prescription and over-the-counter (OTC) products. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin)," the FDA said in a release.

Health problems and liver damage concerns occur because users tend to forget that these prescription combinations have acetaminophen in them. When they take an over the counter Tylenol product on top of acetaminophen prescription products the amount of Tylenol they are consuming is dangerously high. This can be a problem especially when people taking prescription pain relievers routinely, get a cold or some acute condition which they treat over the counter with Tylenol. I saw how easily this can happen when caring for an aging relative. She takes Percocet for arthritis. She completely forgot when she had injured her back, that she was already getting large doses of Tylenol. The extra Tylenol as creates more problems when user drink alcohol and take it.

Prescription acetaminophen based pain reliever users should note. This is not a product recall. You may continue using your Percocet, Vicodin or Tylenol with Codeine as directed. This changes will go into affect with new products. New 325 mg. strength products will also be phased in over a period of three years, to prevent concern of a shortage. Acetaminophen is a common ingredient in over-the-counter headache remedies, pain relievers, arthritis medications and cold and sinus products. Over the counter products are not affected by the changes. If you are taking a prescription pain reliever be aware than 4,000 is the maximum amount of Tylenol you should take daily. Be sure to add in all sources of acetaminophen in your total.

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