FDA Approves Acetaminophen/Naproxen Sodium

The fixed-dose combination product combines acetaminophen with naproxen sodium and is labeled to provide up to 12 hours of temporary pain relief.

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The FDA has approved Tylenol with Naproxen, a fixed-dose combination of acetaminophen and naproxen sodium for over-the-counter use.
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The product is indicated for temporary relief of minor aches and pains in adults and pediatric patients aged 12 years and older.
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Tylenol with Naproxen is dosed every 12 hours and provides up to 12 hours of pain relief.
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The labeling includes warnings about liver damage, stomach bleeding, and increased risk for heart-related issues.
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Pregnant or breastfeeding patients are advised to consult a healthcare professional before using the product.

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