Tylenol

When used appropriately, side effects with acetaminophen are not common.

The most common side effects are rash, nausea, and headache.

Other important side effects include:

• Hypersensitivity reactions
• Serious skin reactions
• Kidney damage
• Anemia
• Reduced number of platelets in the blood (thrombocytopenia)

Chronic alcohol use may also increase the risk of stomach bleeding. The most serious side effect is liver damage due to large doses, chronic use or concomitant use with alcohol or other drugs that also damage the liver.

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

This package is intended for institutional use only. Keep this and all drugs out of the reach of children.

Uses

For Hospital and Government Use Only

Temporarily relieves minor aches and pains due to: the common cold, headache, backache, minor pain of arthritis, toothache, premenstrual and menstrual cramps, and temporarily reduces fever.

Inactive ingredients

Carnauba wax, castor oil, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.

Storage

Store between 20-25°C (68-77°F)

Other

See New WARNINGS Information

Distributed By: Mcneil Consumer Healthcare, Division Of Mcneil - ppc, Inc., Fort Washington, PA 19034 USA

• Fever
• Gout (Gouty Arthritis)
• Measles
• Muscle Cramps
• Neck Pain (Cervical Pain)
• Premenstrual Syndrome (PMS)
• Rotator Cuff Disease
• Sciatica
• Shin Splints
• Toothache

Tylenol is part of the drug class:

• Anilides

Use Tylenol exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take more than your recommended dose. An overdose of acetaminophen 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.

• 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.

If you are treating a child, use a pediatric form of Tylenol. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. If you do not have a dose-measuring device, ask your pharmacist for one. Carefully follow the dosing directions on the medicine label.

You may need to shake the liquid before each use. Follow the directions on the medicine label.

The Tylenol Meltaways chewable tablet must be chewed thoroughly before you swallow it. The tablet will soften in mouth for ease of chewing.

Stop taking Tylenol and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 7 days of use (or 5 days if treating a child);

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Tylenol.

Store at room temperature away from heat and moisture.

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

In rare cases, Tylenol may cause a severe skin reaction that can be fatal. This could occur even if you have taken 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. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop taking this medication and call your doctor at once if you have:

• nausea, upper stomach pain, itching, loss of appetite;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

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 FDA at 1-800-FDA-1088.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Rarely, may cause itchiness, constipation, nausea, vomiting, headache, insomnia, and agitation. May cause gastrointestinal side effects at high dosages.
• The potential for liver damage exists, even at recommended dosages. The risk is increased with higher dosages, a shorter interval between doses, in people who drink three or more alcoholic drinks per day, when taken with other medications that also contain acetaminophen, and in patients with pre-existing liver disease.
• Considered less effective for pain relief than NSAIDs but associated with a lower risk of side effects.
• May not be suitable for some people including people who regularly consume three or more glasses of alcohol per day and those with liver disease.
• May interact with some other medications including warfarin.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Tylenol is an effective mild pain reliever with a low risk of side effects.

• May be administered without regards to food; although food may decrease any reported stomach upset.
• Do not exceed the recommended dosage, because this may put you at risk of liver toxicity. Adults and teenagers who weigh at least 110 pounds (50kg) should not take more than 1000mg of acetaminophen in one dose or more than 4000mg in 24 hours. Children younger than 12 years should only take the dosage recommended to them on the label (this varies depending on their weight and age).
• Always seek your doctor's advice before administering acetaminophen to children aged less than two. If you are giving pediatric liquid Tylenol, always use the dosing syringe provided, or another suitable properly calibrated measure. Do NOT use a kitchen teaspoon.
• Be careful not to administer other products containing acetaminophen at the same time. Acetaminophen is often an ingredient in combination cold and flu remedies.
• Contact your doctor if your symptoms worsen, if redness or swelling occurs in the painful area, if fever lasts longer than 3 days (all ages), or for persistent pain (excluding sore throat) of longer than 10 days in adults, 5 days in children and adolescents, or 3 days for infants.
• Contact your doctor immediately if you or your child have a sore throat that is severe, persists for longer than 2 days, or is followed by fever, rash, headache, nausea, or vomiting.
• Men should not drink more than two alcoholic drinks a day and women no more than one alcoholic drink per day while taking Tylenol.
• Seek urgent medical attention if you develop pain in your upper abdomen, dark urine, loss of appetite, yellowing of the skin or eyes or clay-colored stools.
• Do not take Tylenol without your doctor's advice if you are pregnant.