WASHINGTON, DC (WOWO) — The Food and Drug Administration has approved the first over-the-counter pain medication that combines the active ingredients found in Tylenol and Aleve into a single tablet.
The new medication combines acetaminophen, the pain-relieving ingredient in Tylenol, with naproxen, the active ingredient in Aleve. The approval gives consumers access to a nonprescription option that uses two widely available pain relievers in one product.
The combination is designed to provide both fast-acting and longer-lasting pain relief and has been approved for up to 12 hours of relief for common conditions, including headaches, back pain, muscle aches, toothaches, menstrual cramps and minor arthritis pain.
Doctors have recommended using acetaminophen and naproxen together in some cases for years, but the FDA approval marks the first time the two medications have been combined into a single over-the-counter product with a specific dose evaluated for safety and effectiveness.
Clinical studies found the combination provided stronger pain relief than either medication used alone.
Medical experts say the approval could give consumers another non-opioid option for managing everyday pain, but they also warn that the medication should be used carefully.
Acetaminophen can cause serious liver damage if taken in excessive amounts, especially when combined with other medications that also contain acetaminophen.
Naproxen is part of a class of drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs. Those medications can increase the risk of stomach bleeding, ulcers, heart attack, stroke and kidney problems, particularly when used more frequently or for longer periods than recommended.
Doctors advise consumers to carefully read the medication label before taking the new product.
One concern is accidentally combining multiple medications that contain acetaminophen. Health experts say people taking the new combination medication should avoid taking additional Tylenol products unless directed by a healthcare provider.
The medication may not be appropriate for everyone. People with liver disease, a history of stomach ulcers or bleeding, kidney disease, heart disease or those who are pregnant should consult a healthcare professional before use.
Doctors also recommend following the dosing instructions, avoiding taking more than the recommended amount and seeking medical advice if pain continues for several days or becomes severe.
Health experts say while expanded access to non-opioid pain relief options may benefit many patients, persistent or worsening pain can be a sign of a more serious medical condition that requires evaluation.
