Today, the FDA approved a combination of acetaminophen and naproxen sodium tablets, 325 mg/110 mg for minor pain as an over-the-counter product for 12-hour pain relief. FDA says in a press release (here): “This nonprescription product is indicated for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis in adults and children 12 years and older”. The Agency announcement states that “[W]hile other combination acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) products currently exist on the market, this is the first product to combine naproxen sodium with acetaminophen”. The product to be marked as Tylenol with Naproxen is manufactured by Kenvue Brands LLC.
Because there are other prescription as well as over the counter products that contain acetaminophen or naproxen sodium, consumers are warned to be certain that they are not taking other products concurrently that may contain either of these ingredients.
Approval of a combination of two active ingredients must demonstrate that each component of the drug must contribute to its effectiveness. The product was approved as safe and effective for its labeled indications and will have patient labeling providing warnings similar to those for other single entity acetaminophen and naproxen sodium products. The Drug Facts labeling (here) provides other warnings regarding use during pregnancy.
