Acetaminophen and Naproxen

On September 22, 2025, the Food and Drug Administration (FDA), issued a safety warning indicating that taking acetaminophen while pregnant may be associated with the development of neurological conditions such as Autism Spectrum Disorder (ASD) or Attention Hyperactivity Deficit Disorder (ADHD) in children. Although no evidence to date has been able to show that acetaminophen in pregnancy causes these disorders, some studies have shown an association. Talk to your doctor about the risks and benefits or using acetaminophen during pregnancy.

Taking too much acetaminophen can cause liver damage, sometimes serious enough to require liver transplantation or cause death. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen.

To be sure that you take acetaminophen safely, you should

• not take more than one product that contains acetaminophen at a time. Read the labels of all the prescription and nonprescription medications you are taking to see if they contain acetaminophen. Be aware that abbreviations such as APAP, AC, Acetaminophen, Acetaminoph, Acetaminop, Acetamin, or Acetam may be written on the label in place of the word acetaminophen. Ask your doctor or pharmacist for help to determine if the product you are taking contains acetaminophen.
• take acetaminophen exactly as directed on the prescription or package label. Do not take more acetaminophen or take it more often than directed, even if you still have fever or pain.
• not take more than 4000 mg of acetaminophen per day from all sources. Ask your doctor or pharmacist if you need help determining how much acetaminophen you can take.
• tell your doctor if you have or have ever had liver disease.
• not take acetaminophen if you drink three or more alcoholic drinks every day. Talk to your doctor about the safe use of alcohol while you are taking acetaminophen.
• stop taking your medication and call your doctor right away if you think you have taken too much acetaminophen, even if you feel well.

People who take nonsteroidal anti-inflammatory drugs (NSAIDs), other than aspirin, such as naproxen may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. These problems may develop at any time during treatment, but the risk may be higher for people who take NSAIDs for a long time or at higher doses. Do not take an NSAID such as naproxen if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take naproxen right before or right after the surgery.

NSAIDs such as naproxen may cause ulcers, bleeding, or holes in the esophagus (tube between the mouth and stomach), stomach, or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time or at higher doses, are older in age, have poor health, who smoke, or who drink large amounts of alcohol while taking naproxen. Be sure to tell your doctor or pharmacist about what prescription and nonprescription medications, herbals, and vitamins you take, or plan to take, during your treatment with acetaminophen and naproxen. Certain medications may increase the risk of bleeding occuring. Tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, other bleeding disorders, or liver disease. If you experience any of the following symptoms, stop taking naproxen and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Acetaminophen and naproxen is used for the temporary relief of minor aches and pains. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation

Acetaminophen and naproxen comes as a tablet to take by mouth. Take it with a full glass of water every 12 hours as needed. Acetaminophen and naproxen may be taken with food to prevent an upset stomach.

Take acetaminophen and naproxen exactly as directed. Do not take more or less of it or take it more often than recommended.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking acetaminophen and naproxen,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor if you have been told to follow a low sodium diet and if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; anemia (red blood cells do not bring enough oxygen to all parts of the body); or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant; or are breast-feeding.Acetaminophen and naproxen may harm the fetus and cause problems with delivery if it is taken around 20 weeks or later during pregnancy. Do not take acetaminophen and naproxen around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while taking acetaminophen and naproxen, call your doctor.
• this medication may not be recommended in people 65 years or older. There may be other treatment options that are safer or work better. Talk to your doctor about the risks and benefits of taking this medication.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking acetaminophen and naproxen.
• ask your doctor about the safe use of alcoholic beverages while you are taking acetamiophen and naproxen. Alcohol can make the side effects from acetaminophen and naproxen worse.

Unless your doctor tells you otherwise, continue your normal diet.

This medication is usually taken as needed. If your doctor has told you to take acetaminophen and naproxen regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Acetaminophen and naproxen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• gas
• excessive thirst
• headache
• dizziness
• lightheadedness
• drowsiness
• difficulty falling asleep or staying asleep
• burning or tingling in the arms or legs
• cold symptoms
• ringing in the ears
• hearing problems

Some side effects can be serious. If you experience any of these symptoms {or those listed in the IMPORTANT WARNING section}, stop taking acetaminophen and naproxen and call your doctor immediately or get emergency medical treatment:

• changes in vision; swelling in the abdomen, ankles, feet, or legs; chest pain or fast heartbeat; slurred speech; confusion
• feeling that the tablet is stuck in your throat
• weakness, excessive tiredness, pain in the upper right part of the stomach, loss of appetite, nausea, diarrhea, yellowing of the skin or eyes, flu-like symptoms, or dark urine
• bruises or purple blotches under the skin; vomiting blood, dizziness, bloody or black stools

Acetaminophen and naproxen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea, vomiting, loss of appetite; upper belly pain
• yellowing of the skin or eyes
• sweating
• extreme tiredness or flu-like symptoms
• unusual bleeding or bruising

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking acetaminophen and naproxen.

Ask your pharmacist any questions you have about acetaminophen and naproxen.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Tylenol^® with Naproxen