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Notable Approval:
FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief
On July 24, FDA approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg tablets), the first fixed-dose combination product to pair acetaminophen with naproxen sodium in a single combination tablet for up to 12 hours of pain relief. 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.
This action aligns with President Trump’s The Great Healthcare Plan, a federal effort to make more verified safe pharmaceutical drugs available for over-the-counter purchase. This will lower healthcare costs and increase consumer choice by strengthening price transparency, increasing competition, and reducing the need for costly and time-consuming doctor’s visits.
Condition
Minor aches and pains are some of the most common reasons Americans reach for a nonprescription (or, over-the-counter, OTC) medication. Acetaminophen and naproxen sodium are among the most widely used OTC pain relievers in the United States, each with decades of established use and well-characterized safety profiles. Together in a single tablet, the two active ingredients are combined to provide consumers with a new nonprescription option for up to 12 hours of pain relief. While 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.
Data Supporting Tylenol with Naproxen
The approval was supported by evidence establishing the effectiveness and safety of the combination drug and demonstrating the contribution of each ingredient to the overall pain relief effect of the combination. Tylenol with Naproxen is dosed every 12 hours. The labeling for Tylenol with Naproxen is consistent with other nonprescription products in its class and includes standard warnings applicable to both acetaminophen- and NSAID-containing products.
Safety Information
As with all acetaminophen-containing products, consumers are warned not to use Tylenol with Naproxen with other drugs containing acetaminophen, as doing so may cause liver damage. As with all NSAID-containing products, the labeling includes warnings for stomach bleeding and for increased risk of heart attack, heart failure, and stroke — risks that are higher when NSAIDs are used more than directed or for longer than directed.
The labeling for Tylenol with Naproxen includes pregnancy-related recommendations consistent with all other acetaminophen- or NSAID-containing nonprescription products. Specifically, the label advises that those who are pregnant or breast-feeding ask a health professional before use. Also, the Drug Facts label indicates it is important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor.
FDA encourages all consumers to read and follow the labeling carefully and to consult a healthcare provider if they have unanswered questions.
Tylenol with Naproxen is manufactured by Kenvue Brands LLC.
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