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The Food and Drug Administration (FDA) has approved the combination of acetaminophen 325 mg and naproxen sodium 110 mg tablets as the first fixed-dose, over-the-counter (OTC) product to pair these 2 pain relief ingredients. The label recommends 1 dose every 12 hours for adults and children aged 12 years and older. It is indicated for temporary relief of common complaints such as headache, muscular aches, and back pain. And like other naproxen products, it should not be used at 20 weeks’ gestation or later because of fetal renal effects and oligohydramnios concerns. According to the manufacturer, Kenvue, the combination product demonstrates superior pain relief compared with either acetaminophen alone or naproxen alone, evidence of which will be presented at upcoming medical congresses. There is no specific date for availability, but OTC products often reach store shelves quickly once approved.
Additive effects of combination drug: For urgent care clinicians, this approval is less about a new nonopioid pain drug than about a new OTC formulation. Combining acetaminophen with a nonsteroidal anti-inflammatory drug is already common practice in acute pain management. However, the 2 drugs work through different mechanisms with additive effects, so clinicians should be aware when patients use the new combination drug to avoid recommending duplicate acetaminophen or naproxen.