Acetaminophen

Acetaminophen is used for the short-term relief of minor aches and pains due to colds, flu, headache, backache, arthritis, toothache, muscle pain, and menstruation. It also temporarily reduces fever. Outside of the United States, Canada, and Japan, acetaminophen is called paracetamol.

For pain control after surgery, prescription intravenous (IV) acetaminophen is available.

Acetaminophen is also available in combination with many other medications (see below). Always check the label to see if a combination product contains acetaminophen. You should never take two products containing acetaminophen together.

Take exactly as directed on the Package Insert for your acetaminophen product.

• Instructions vary depending on the formulation.
• Do not use for more than 10 days in adults unless directed by a doctor. Do not use for more than 5 days in children under 12 years unless directed by a doctor.

Taking more than the recommended dose of acetaminophen may cause liver damage.

• In case of overdose, get medical help or contact a Poison Control Center right away (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.

Stop taking acetaminophen and talk to a doctor if you:

• have a sore throat that is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting
• Still have a fever after 3 days of use
• If pain gets worse or lasts more than 10 days in adults or more than 5 days in children under 12 years.
• Have a skin rash, ongoing headache, nausea, vomiting, redness, or swelling
• Have worsening symptoms or new symptoms.

These could be signs of a serious condition.

Absolute Contraindications

Do not use acetaminophen:

• 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 or any of the inactive ingredients in this product.
• If you have severe liver disease (applies to the prescription intravenous injection).

Ask a doctor before use if you have liver disease or if the patient is a child with pain caused by arthritis.

Caution Needed

Before taking acetaminophen, talk to a doctor or pharmacist about taking it, especially if you:

• Have liver disease
• Have severe kidney disease
• Drink alcohol
• Take anticoagulants such as warfarin
• Are pregnant or breastfeeding.

Acetaminophen Use During Pregnancy: What the Evidence and FDA Say

Acetaminophen is the pain and fever medicine most often recommended in pregnancy. ACOG and other professional bodies, including the European Medicines Agency, continue to list it as a first-line option.

What the research shows

Some observational studies have reported a link between acetaminophen use in pregnancy and later autism or ADHD diagnoses, particularly with prolonged use. That study design cannot separate the medicine from the reasons it was taken, such as fever or infection, or from shared family and genetic factors.

Studies designed to account for those factors have not found a causal link. A sibling-control analysis of more than 2 million Swedish children (JAMA, 2024) found no increased risk of autism, ADHD, or intellectual disability, and a systematic review of 43 studies (The Lancet, January 2026) reached the same conclusion. Research continues, but the largest and best-controlled analyses do not support a causal relationship.

What the FDA has done

On September 22, 2025, the FDA began the process of changing acetaminophen labeling to reflect a possible association with neurological conditions, including autism and ADHD, and wrote to physicians about it. The same announcement noted that no causal relationship has been established and that acetaminophen remains the only over-the-counter option for treating fever in pregnancy. Kenvue, which makes Tylenol, opposed the change.

As of August 18, 2026, marketed US labels carry only the standard statement, "If pregnant or breast-feeding, ask a health professional before use."

Practical points

• Untreated high fever in pregnancy carries risks of its own.
• NSAIDs such as ibuprofen and naproxen are generally avoided from 20 weeks unless a doctor directs otherwise, and aspirin is not recommended for routine pain relief.
• Use the lowest effective dose for the shortest time needed, and discuss repeated or ongoing use with your doctor, midwife, or pharmacist.

Common Side Effects

Over-the-counter Drug Facts labeling for single-ingredient acetaminophen does not list adverse reactions. The side effects below are drawn from the professional monograph and post-marketing reports.

The most common side effects of acetaminophen are:

• Nausea
• Stomach pain
• Loss of appetite
• Headache.
• Vomiting, constipation, or trouble sleeping (insomnia).

Skin rash or itching may occasionally occur.

Serious side effects are rare but can include liver damage with overdose or prolonged high-dose use. Allergic reactions are uncommon.

Acetaminophen and Liver Damage

Acetaminophen can damage your liver. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours or 5 caplets in 24 hours for children (in children, the maximum dose depends on their body weight, see the package dosing instructions). Severe liver damage may occur if you take:

• More than 4,000 mg of acetaminophen in 24 hours (adults) or more than 5 doses in 24 hours (child), which is the maximum daily amount
• With other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while taking acetaminophen.

Stop taking acetaminophen and call your doctor at once if you have signs of liver problems:

• Stomach pain (upper right side)
• Loss of appetite
• Tiredness
• Itching
• Dark urine, clay-colored stools
• Jaundice (yellowing of the skin or eyes).

Allergic Reactions

Get emergency medical help if you have signs of an allergic reaction to acetaminophen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Severe Skin Reactions

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal, even if you took acetaminophen in the past and had no reaction. The FDA has warned that acetaminophen has been associated with three rare but serious skin conditions:

• Stevens-Johnson syndrome (SJS)
• Toxic epidermal necrolysis (TEN)
• Acute generalized exanthematous pustulosis (AGEP).

SJS and TEN typically begin with flu-like symptoms followed by a spreading rash that blisters and peels, and can affect the eyes, mouth and other mucous membranes. AGEP usually appears as a sudden eruption of small pus-filled bumps and generally clears within about two weeks of stopping the drug.

Stop taking acetaminophen and seek medical help right away if you develop skin reddening, blisters, or a rash. If you have ever had a serious skin reaction to acetaminophen, do not take it again, and tell your doctor and pharmacist.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal, even if you took acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Notes:

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Directions differ by strength and formulation, so always follow the pack you have. The table below sets out the label directions for the most widely sold single-ingredient acetaminophen products.

Weight-based dosing for oral suspension (160 mg/5 mL)

Dose by weight where possible, and use age only if the weight is not known.

Use only the dosing cup, syringe or dropper supplied with that product, and do not use it to measure a different product. Concentrations differ between products.

Maximum Safe Doses

• Adults and children 12+ years: No more than 1,000 mg per dose or a maximum of 4,000 mg per day from all sources combined
• Children under 12 years: No more than 5 doses in 24 hours, using only the number of milligrams per dose recommended for the child's weight and age. Do not exceed the recommended dosage for your child's age or weight.

Note: 4,000 mg a day is the absolute upper limit for adults, not a target. Many product labels direct a lower daily maximum, for example 3,000 mg for Extra Strength 500 mg caplets. Always follow the directions on the pack you have, and remember that the limit applies to all acetaminophen you take, including the amount in combination cold, flu, sleep and prescription pain products.

Always consult a doctor before giving:

• Solid oral 325 mg caplets to children under 6 years
• Extra Strength 500 mg to children under 12 years
• 650 mg extended-release to children under 18 years
• Children's suspension to children under 2 years.

Dosage form options include:

• Regular strength (325 mg) and extra-strength (500 mg) oral tablets or capsules
• Extended-release 8-hour formulations (650 mg)
• Rapid-release gel caps
• Oral liquids
• Chewable or orally-disintegrating oral tablets
• Effervescent tablets and granules
• Oral powder
• Rectal suppositories
• An intravenous injection (prescription only).

Acetaminophen is available over-the-counter (OTC) in the United States at retail shops, including pharmacies, grocery stores, large retail stores like Target or Walmart, and gas station markets. You do not need a prescription to purchase acetaminophen for children or adults.

Acetaminophen is available as brand-name products such as Tylenol, Children's Tylenol, or Mapap, and also as generics and store-based brands like Equate acetaminophen (from Walmart) or Up and Up acetaminophen (from Target). The list of U.S. brand names for acetaminophen includes:

• Actamin
• Anacin AF
• Aurophen
• Bromo Seltzer
• Children's Tylenol
• Infant's Tylenol Suspension
• Leader 8 Hour Pain Reliever
• Mapap
• M-Pap
• Pharbetol
• Silapap Childrens
• Tactinal
• Tempra Quicklets
• Tycolene
• Tylenol
• Vitapap.

• Chewable tablets: Chew completely before swallowing. Some chewable products are sweetened with aspartame and carry a phenylketonurics warning stating the amount of phenylalanine per tablet. Check the label if you or your child has phenylketonuria (PKU)
• Disintegrating tablets: With dry hands, place on tongue and let dissolve, don't chew or swallow whole
• Extended-release tablets: Swallow whole; do not crush, chew, split, or dissolve. Children under 18 ask a doctor before use
• Liquid suspension: Shake well before each use
• Effervescent granules and tablets: Dissolve one packet in at least 4 ounces of water, stir, and drink immediately. Add more water to a glass, swirl, and drink to get the full dose. Effervescent products contain sodium, and the label states how much each dose contains. If you are on a sodium-restricted diet, ask a doctor before use
• Oral powder: Place directly on the tongue and swallow
• Suppository: Unwrap the suppository, lie on your side, gently insert the pointed end into your rectum, and remain lying down for a few minutes.
• Intravenous injection: Administered by a healthcare provider as a 15-minute infusion.

Critical Safety Warning for Infants

Infant formulations come in different concentrations, each with its own specific dropper or syringe.

• Never mix dosing devices between products.
• Using the wrong device can cause a dangerous overdose.
• Only use the measuring device that comes with that specific product.
• Dosing is based on the child's age and weight.
• Follow the package instructions carefully.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

• The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness.
• Later symptoms may include upper abdominal pain, dark urine, and yellowing of your skin or the whites of your eyes.
• Acetaminophen overdose is a leading cause of acute liver failure in the United States, and in some cases has led to liver transplant or death. Antidote treatment works best when it is started early, so do not wait for symptoms to appear before getting help.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication.

• Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines.
• Taking certain products together can cause you to get too much acetaminophen, which can lead to a fatal overdose.
• Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Avoid using other medicines that may contain acetaminophen.

Prescription combination products: liver safety limits

Prescription products that combine acetaminophen with another medicine, such as an opioid, are subject to two FDA requirements aimed at preventing liver injury:

• A 325 mg limit per dosage unit. The FDA asked manufacturers to limit acetaminophen to 325 mg per tablet, capsule, or other dosage unit in prescription combination products, so that a person taking two dosage units at a time is less likely to exceed the daily limit.
• A boxed warning. Prescription acetaminophen combination products carry a boxed warning about the potential for severe liver injury, including cases that have resulted in liver transplant and death.

If you take a prescription pain medicine, check whether it contains acetaminophen or APAP before adding any over-the-counter product that also contains it.

Acetaminophen/opioid combination formulations

Acetaminophen can also be used for moderate to severe pain in combination with opioids such as codeine, hydrocodone, oxycodone, butalbital + caffeine, and tramadol, as the following preparations:

• Acetaminophen/benzhydrocodone. Brand Name: Apadaz
• Acetaminophen/butalbital/caffeine. Brand Names: Fioricet, Zebutal, Vanatol S, Vtol LQ
• Acetaminophen/codeine. Brand Name: Tylenol With Codeine
• Acetaminophen/dihydrocodeine/caffeine. Brand Name: Trezix, Dvorah, Panlor DC, Panlor SS, Zerlor
• Acetaminophen/hydrocodone. Brand Names: Hycet, Lorcet, Norco, Vicodin, Xodol, Zamicet
• Acetaminophen/oxycodone. Brand Names: Endocet, Nalocet, Percocet, Primlev, Roxicet
• Acetaminophen/tramadol. Brand Name: Ultracet.

Note: Some brand names have been discontinued.

Acetaminophen Combinations for Cold & Flu Relief

Acetaminophen in combination with diphenhydramine, phenylephrine, chlorpheniramine, or guaifenesin can be used to relieve symptoms such as pain, nasal congestion, cough, cold, and flu symptoms.

• Acetaminophen/dextromethorphan/phenylephrine. Brand Names: Cold and Flu Daytime Relief, Comtrex Cold and Cough, DayQuil Cold and Flu
• Acetaminophen/chlorpheniramine/dextromethorphan. Brand Names: Coricidin HBP Maximum Strength Flu, Children's Tylenol Cold + Cough + Runny Nose, Mapap Cough and Sinus Formula, Triaminic Multi-Symptom Fever
• Acetaminophen/dextromethorphan/guaifenesin/phenylephrine. Brand Names: DayQuil Severe Cold and Flu, Mucinex Children's Cold, Cough and Sore Throat, Tylenol Cold and Flu Severe
• Acetaminophen/chlorpheniramine/dextromethorphan/guaifenesin. Brand Names: Coricidin HBP Day/Night Cold

Acetaminophen Combinations for Headache & Pain Relief

Acetaminophen in combination with aspirin, caffeine, ibuprofen or naproxen sodium can be used to manage tension headaches and migraines, and provide relief from mild to moderate pain, such as that caused by toothache, backache, menstrual pain, muscle aches, and minor arthritis pain.

• Acetaminophen/aspirin/caffeine. Brand Names: Anacin Advanced Headache Formula, Arthriten, Excedrin, Excedrin Migraine, Excedrin Extra Strength, Goody's Headache Powders, Migraine Relief
• Acetaminophen/caffeine. Brand Names: Excedrin Tension Headache, Excedrin Quick Tab, Excedrin Mild Headache, Headache Relief, Valorin Extra
• Acetaminophen/ibuprofen. Brand Name: Advil Dual Action With Acetaminophen, Combogesic, Motrin Dual Action with Tylenol
• Acetaminophen/naproxen sodium. Brand Name: Tylenol with Naproxen.

Tylenol with Naproxen

The FDA approved Tylenol with Naproxen on July 24, 2026. It is the first nonprescription fixed-dose combination of acetaminophen and naproxen sodium.

• Each tablet contains acetaminophen 325 mg and naproxen sodium 110 mg.
• The label directs adults and children 12 years and over to take 2 tablets (acetaminophen 650 mg with naproxen sodium 220 mg) every 12 hours while symptoms last, with a full glass of water. Do not take more than 2 tablets in 12 hours or 4 tablets in 24 hours, and do not use for more than 10 days unless a doctor directs.
• Children under 12 years: ask a doctor.

Because this product contains an NSAID, its label carries warnings that single-ingredient acetaminophen products do not:

• Stomach bleeding warning. The risk is higher in people aged 60 and over, those with a history of stomach ulcers or bleeding problems, those taking a blood thinner, a steroid, or another NSAID, those who drink three or more alcoholic drinks a day, and anyone taking more or for longer than directed.
• Heart attack and stroke warning. NSAIDs other than aspirin may increase the risk of heart attack, heart failure and stroke, and the risk is greater with higher doses or longer use than directed.
• Pregnancy. Naproxen sodium should be avoided from 20 weeks of pregnancy onward unless directed by a doctor.

Acetaminophen Combinations for Menstrual Relief

Acetaminophen in combination with pyrilamine, caffeine, or pamabrom can be used to relieve menstrual cramps, muscle aches, headaches, fatigue, and bloating.

• Acetaminophen/caffeine/pyrilamine. Brand Names: GoodSense Menstrual Relief, Midol Complete
• Acetaminophen/pamabrom/pyrilamine. Brand Names: Menstrual Pain Relief, Menstrual PMS, Premsyn PMS.

Acetaminophen combinations for sleep

Acetaminophen is also available in combination with diphenhydramine as a sleep aid and nighttime pain reliever.

• Acetaminophen/diphenhydramine: Brand Names: Legatrin PM, Midol PM, Night Time Pain, Unisom with Pain Relief.

Taking acetaminophen may cause false results with certain blood glucose monitors. If you have diabetes, ask your doctor about the best way to monitor your blood sugar levels while using this medicine.

Warfarin. Regular use of acetaminophen has been reported to raise the INR in people taking warfarin, which increases the risk of bleeding. The effect has been described with repeated daily doses of roughly 1.3 g or more taken over several days, rather than with occasional single doses. Over-the-counter acetaminophen labels direct anyone taking warfarin to ask a doctor or pharmacist before use. If you take warfarin and need acetaminophen regularly, your INR may need to be checked more often.

Combining acetaminophen with alcohol may cause serious liver damage.

Store between 20–25 °C (68–77 °F); do not use if the blister unit is torn or broken.

Keep out of reach of children.