Tylenol with Naproxen

Tylenol with Naproxen is an over-the-counter, long-lasting tablet that combines two pain relievers in one product: acetaminophen 325 mg (an analgesic) and naproxen sodium 110 mg (a nonsteroidal anti-inflammatory drug [NSAID]). Tylenol with Naproxen lasts for 12 hours and is taken twice a day and is used for the temporary relief of minor aches and pains due to:

• headache
• backache
• muscular aches
• toothache
• menstrual cramps
• minor pain of arthritis.

The FDA approved Tylenol with Naproxen on July 24, 2026. It is the first product to bring acetaminophen and naproxen sodium together in a single nonprescription tablet. Other fixed-dose combinations of acetaminophen with an NSAID were already on the US market before this approval, so the point of difference is the pairing with naproxen sodium rather than the combination approach itself.

The FDA has granted the manufacturer Kenvue three years of exclusivity for the new formulation.

The two ingredients in Tylenol with Naproxen relieve pain in different ways and over different timeframes. Acetaminophen acts on how the body registers pain signals and works quickly. Naproxen sodium is an NSAID and eases pain linked to inflammation, with a longer duration of effect. Taken together, the combination is intended to provide an early onset of relief within 30 minutes and keep working across a 12-hour dosing interval. Neither ingredient is an opioid.

• Do not take more than directed (see overdose warning)
• Do not use for more than 10 days unless directed by a doctor
• drink a full glass of water with each dose

• Do not take more than 2 tablets in 12 hours unless directed by a doctor
• Do not take more than 4 tablets in 24 hours unless directed by a doctor

When using this product

• Take with food or milk if stomach upset occurs.

Stop use and ask a doctor if:

• you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better
• you have symptoms of heart problems or stroke: chest pain, trouble breathing, weakness in one part or side of body, slurred speech, leg swelling
• pain gets worse or lasts more than 10 days
• you have difficulty swallowing
• it feels like the pill is stuck in your throat
• redness or swelling is present in the painful area
• any new symptoms occur

These could be signs of a serious condition.

Kenvue reports that the approval was supported by a program of eight clinical studies across a range of pain models. According to the manufacturer, the fixed-dose combination gave greater pain relief than either acetaminophen alone or naproxen sodium 220 mg alone, with relief beginning within 30 minutes and lasting 12 hours after a single dose. The FDA has said the approval rested on evidence of safety and effectiveness for the combination, together with evidence that each ingredient contributes to the overall effect.

Detailed results have not yet been published. The company has said data will be presented at medical meetings later in 2026, including PAINWeek.

• Each tablet contains sodium 10 mg
• Read all warnings and directions before use, and keep the carton
• Store between 20 and 25 degrees C (68 and 77 degrees F)
• Do not use if the foil inner seal imprinted with "Sealed For Your Safety" is broken or missing.

Liver damage warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• with other drugs containing acetaminophen. Do not use with other medicines containing acetaminophen
• more than 4,000 mg of acetaminophen in 24 hours
• 3 or more alcoholic drinks every day while using this product

Acetaminophen allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If a skin reaction occurs, stop use and seek medical help right away.

NSAID allergy alert

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood-thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed.

Heart attack and stroke warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use Tylenol with Naproxen:

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
• if you are allergic to acetaminophen, naproxen sodium, or any other pain reliever, or any of the inactive ingredients in this product
• right before or after heart surgery.

Before taking Tylenol with Naproxen, talk to a doctor before taking if:

• you have liver disease
• the stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic

Talk to a doctor or pharmacist before using if you are:

• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, because naproxen sodium may decrease this benefit of aspirin
• taking the blood-thinning drug warfarin
• taking any other drug.

Pregnancy and breastfeeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

Overdose warning: in case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Active ingredients: acetaminophen 325 mg and naproxen sodium 110 mg

Inactive ingredients: Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

Tablets are supplied in bottles with a push-and-turn cap and a peel-back label, packed in a carton.

Tylenol with Naproxen is distributed by Kenvue Brands LLC. Call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).