The Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)are bioequivalent to the reference listed drug (RLD),Advil Dual Action of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.Advil Dual Action was first available as an over-the-counter drug in 2020.
The pivotal approval, Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg provides relief for multiple pain-related symptoms by combining two powerful ingredients indicated for OTC pain relief, ibuprofen and acetaminophen. Ibuprofen works through the body targeting pain at the source while Acetaminophen block spain signal to the brain. The innovation takes these two powerful pain fighting ingredients and combines them into one tablet to offer fast, strong pain relief. The company plans to launch the product immediately.