Tylenol

Tylenol is a pain reliever and a fever reducer. Tylenol is used to reduce fever and relieve minor pain caused by conditions such as colds or flu, headache, muscle aches, backache, arthritis, toothache, sore throat, menstrual cramps, and fevers. The active ingredient in Tylenol is acetaminophen, the same medicine that is called paracetamol in many other countries.

Unlike ibuprofen, naproxen, and aspirin, acetaminophen is not a nonsteroidal anti-inflammatory drug (NSAID) and does not reduce inflammation. This is why Tylenol is often chosen by people who cannot take NSAIDs, such as those with stomach ulcers or certain kidney or bleeding problems.

Tylenol is sold over the counter in several strengths and forms for adults, children, and infants, and the brand name is also used for a range of combination products that add other active ingredients for sleep, cold, flu and sinus symptoms.

Take Tylenol exactly as directed on the label, or as prescribed by your doctor. An acetaminophen overdose can damage your liver or cause death.

• Adults and teenagers who weigh at least 110 pounds (50 kilograms): Do not take more than 1000 milligrams (mg) at one time. Do not take more than 4000 mg in 24 hours.
• Adults and teenagers who weigh less than 110 pounds (50 kilograms): Ask a doctor for the correct dose. Do not take more than 75 milligrams per kilogram of body weight in 24 hours.
• Children younger than 12 years old: Do not take more than 5 doses of acetaminophen in 24 hours. Use only the number of milligrams per dose that is recommended for the child's weight and age. Use exactly as directed on the label.
• Avoid also using other medicines that contain acetaminophen, or you could have a fatal overdose.

Individual Tylenol products set a lower maximum than 4000 mg. For example, the Drug Facts label for Tylenol Regular Strength states that the maximum daily dose of that product is 10 tablets (3,250 mg) in 24 hours for adults, or 5 tablets (1,625 mg) in 24 hours for children.

Do not give extra-strength Tylenol to a child younger than 12 years old without medical advice.

Tylenol comes in many different forms such as tablets, caplets, capsules, liquid, chewable tablets, and dissolving powders or granules. Acetaminophen can also be given as an injection into a vein. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you need help.

Tylenol Regular Strength 325 mg tablets

Tylenol Extra Strength 500 mg

Tylenol 8 HR Arthritis Pain and Tylenol 8 HR Muscle Aches & Pain, 650 mg extended-release caplets

Children's Tylenol chewable tablets 160 mg

Chew or crush tablets completely before swallowing; do not swallow tablets whole. Find the right dose on the chart below. If possible, use weight to dose; otherwise, use age. Repeat dose every 4 hours while symptoms last. Do not give more than 5 times in 24 hours.

or as directed by a doctor

Children's Tylenol oral suspension 160 mg per 5 mL

Shake well before using. Remove the child protective cap and squeeze your child's dose into the dosing cup. Find the right dose on the chart below. If possible, use weight to dose; otherwise, use age. Repeat dose every 4 hours while symptoms last. Do not give more than 5 times in 24 hours.

or as directed by a doctor

Attention: Use only the enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. Each 5 mL contains sodium 2 mg.

Infants' Tylenol oral suspension 160 mg per 5 mL

Infants' Tylenol comes with its own oral syringe. Shake well before using and use only the enclosed syringe, which is designed specifically for this product. Repeat dose every 4 hours while symptoms last, and do not give more than 5 doses in 24 hours. Children under 24 lbs or under 2 years should be dosed only on the advice of a doctor.

Stop taking this medicine and call your doctor if:

• you still have a sore throat after 2 days of use;
• you still have a fever after 3 days of use;
• you still have pain after 10 days of use in adults, or 5 days in children under 12;
• you have a skin rash, ongoing headache, nausea, vomiting, redness or swelling; or
• your symptoms get worse, or if you have any new symptoms.

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 Tylenol.

Store at room temperature away from heat and moisture. Most Tylenol products should be stored between 20-25°C (68-77°F). Do not use the product if the carton is opened, or if the foil inner seal or bottle wrap imprinted with "TYLENOL" is broken or missing.

You should not take Tylenol if you are allergic to acetaminophen or to any of the inactive ingredients in the product, or if you have severe liver disease.

Do not take this medicine without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis), if you have 3 or more alcoholic drinks every day, or if you have severe kidney disease, chronic malnutrition, or severe hypovolemia (low blood volume). You may not be able to take Tylenol.

Ask a doctor before use if the user has liver disease, or is a child with pain of arthritis. Ask a doctor or pharmacist before use if the user is taking the blood-thinning drug warfarin.

Pregnancy and breastfeeding

Your doctor will determine whether Tylenol is safe for you to use during pregnancy. Do not use this medicine without the advice of your doctor if you are pregnant. Acetaminophen is the only over-the-counter medicine approved to treat fever during pregnancy; However, people who are pregnant and need to treat pain or fever should discuss the options with their doctor or midwife.

Acetaminophen passes into breast milk in small amounts and is one of the pain and fever medicines most commonly used while breastfeeding. Ask a doctor before using this medicine if you are breastfeeding.

Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

• 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

Ask a doctor before use if the user

• has liver disease
• is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is taking the blood-thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present.

These could be signs of a serious condition.

Less serious Tylenol side effects may be more likely, and you may have none at all.

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.

If pregnant or breast-feeding, ask a health professional before use.

Overdose warning

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.

Tylenol products differ in how much acetaminophen they contain, how often they are taken, and which age groups they are made for. Always check the Drug Facts label on the specific package you have, because the maximum daily amount is not the same for every product.

Acetaminophen injection is also available in hospital settings for pain relief. A Tylenol rectal suppository has been discontinued.

Children's and Infants' Tylenol are the same strength. Both liquids contain 160 mg of acetaminophen per 5 mL. The difference is the dosing device: Infants' Tylenol comes with an oral syringe, and Children's Tylenol comes with a dosing cup. Use only the device supplied with the product. Measuring with the wrong device may cause an overdose.

Alongside the single-ingredient products, the Tylenol name is used on a number of combination medicines that pair acetaminophen with other active ingredients. These products carry all the warnings that apply to acetaminophen plus the warnings that apply to the added ingredients.

Tylenol with Naproxen is the first nonprescription fixed-dose combination of acetaminophen and naproxen sodium approved in the United States. Because it contains an NSAID, it carries NSAID stomach bleeding and cardiovascular warnings that do not apply to acetaminophen-only Tylenol products, and it should not be used from 20 weeks of pregnancy onward unless directed by a doctor.

Important: Some combination products may contain acetaminophen even when the name does not say so. Taking a Tylenol combination product together with another acetaminophen product can result in a fatal overdose. Check the label of every medicine you take for acetaminophen or APAP.

Since Tylenol is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

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 Tylenol.

Other drugs may interact with acetaminophen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor if you take a blood thinner such as warfarin. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.