Tylenol with Naproxen is a nonprescription pain medicine that combines acetaminophen and naproxen sodium in one tablet. Each tablet contains 325 mg of acetaminophen and 110 mg of naproxen sodium.
Acetaminophen helps reduce pain, while naproxen sodium is a nonsteroidal anti-inflammatory drug, or NSAID, that reduces pain and inflammation. Combining the two ingredients may provide pain relief for up to 12 hours.
The FDA approved Tylenol with Naproxen in July 2026 for adults and adolescents aged 12 years and older. It is intended for short-term treatment of minor aches and pains and should only be taken according to the directions on the label.
Indications for use
Tylenol with Naproxen is indicated for the temporary relief of minor aches and pains caused by:
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Headache
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Backache
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Muscle aches
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Toothache
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Menstrual cramps
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Minor arthritis pain
This medication is not intended for long-term pain treatment unless recommended by a healthcare professional.
How to take it
Adults and children aged 12 years and older should take 2 tablets every 12 hours as needed. Each dose provides 650 mg of acetaminophen and 220 mg of naproxen sodium.
The tablets should be swallowed with a full glass of water. Taking the medicine with food or milk may help reduce stomach discomfort.
No more than 4 tablets should be taken within 24 hours. This maximum daily amount contains 1,300 mg of acetaminophen and 440 mg of naproxen sodium.
Tylenol with Naproxen should not be used for more than 10 days for pain unless a doctor recommends a longer treatment period. Medical advice is also recommended if symptoms become worse, new symptoms appear, or redness or swelling is present.
Possible side effects
Tylenol with Naproxen may cause stomach discomfort, nausea, heartburn or dizziness. Some effects may be related to acetaminophen, while others may be caused by naproxen sodium.
Although uncommon, serious side effects can occur, such as liver injury, stomach bleeding, heart attack and stroke, allergic and skin reactions, and kidney and fluid-related problems.
Contraindications for use
Tylenol with Naproxen should not be used by people who are allergic to acetaminophen, naproxen, aspirin, other NSAIDs or any ingredient in the product. It should also be avoided by anyone taking another medication that contains acetaminophen or another NSAID, such as ibuprofen or additional naproxen, unless advised by a healthcare professional.
This medicine should not be used immediately before or after coronary artery bypass graft surgery.
edical advice is also recommended for people who regularly consume alcohol or take warfarin, other blood thinners, corticosteroids, diuretics, low-dose aspirin or other prescription medicines.
Use during pregnancy and breastfeeding
Naproxen and other NSAIDs should generally be avoided from 20 weeks of pregnancy onward unless specifically recommended by a healthcare professional. Use during this stage may cause fetal kidney problems and low levels of amniotic fluid.
NSAID use later in pregnancy may also cause complications affecting the fetal heart or delivery. Pregnant or breastfeeding people should obtain medical advice before taking Tylenol with Naproxen.
Drug and alcohol precautions
Other medications should be checked carefully for acetaminophen, naproxen, aspirin, ibuprofen or another NSAID. Taking more than one product with the same or similar ingredients may lead to overdose, liver injury, stomach bleeding or kidney problems.
Alcohol may increase the risk of liver damage from acetaminophen and stomach bleeding from naproxen. Extra caution is necessary for people who regularly consume three or more alcoholic drinks per day.
When to seek medical attention
Immediate medical care is necessary if symptoms of liver damage, stomach bleeding, a severe allergic reaction, heart attack, stroke or a serious skin reaction occur.
Medical advice is also recommended if pain lasts for more than 10 days, symptoms worsen, new symptoms appear, or swelling and redness develop.