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|Acetaminophen Controlled-Release Tablets

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Acetaminophen Controlled-Release Tablets

Generic Name: Acetaminophen Controlled-Release Tablets (a-seet-a-MIN-oh-fen)
Brand Name: Examples include Tylenol 8 Hour and Tylenol Arthritis Pain

Acetaminophen Controlled-Release Tablets is used for:

Treating minor aches and pains due to headache, muscle aches, backache, arthritis, the common cold, menstrual cramps, and toothache.

Acetaminophen Controlled-Release Tablets is an analgesic and antipyretic (lowers fever). It works by lowering a chemical in the brain that stimulates pain nerves and the heat-regulating center in the brain.

Do NOT use Acetaminophen Controlled-Release Tablets if:

you are allergic to any ingredient in Acetaminophen Controlled-Release Tablets

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen Controlled-Release Tablets:

Some medical conditions may interact with Acetaminophen Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of alcohol abuse or you drink more than 3 alcohol-containing drinks every day
if you have liver or kidney problems or hepatitis

Some MEDICINES MAY INTERACT with Acetaminophen Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Isoniazid because the risk of liver problems may be increased
Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Acetaminophen Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen Controlled-Release Tablets:

Use Acetaminophen Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Acetaminophen Controlled-Release Tablets by mouth with or without food.
Swallow Acetaminophen Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
Replace original bottle cap to maintain child resistance.
If you miss a dose of Acetaminophen Controlled-Release Tablets and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen Controlled-Release Tablets.

Important safety information:

Acetaminophen Controlled-Release Tablets has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
Acetaminophen Controlled-Release Tablets may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen Controlled-Release Tablets. Talk to your doctor before you take Acetaminophen Controlled-Release Tablets or other fever reducers if you drink more than 3 drinks with alcohol per day.
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use for more than 2 days or give to children younger than 3 years old unless directed by a doctor.
Acetaminophen Controlled-Release Tablets may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Acetaminophen Controlled-Release Tablets and need to check your blood cholesterol at home.
For pain and fever in ADULTS: Stop use of Acetaminophen Controlled-Release Tablets and ask your doctor if pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, or new symptoms occur or redness or swelling is present.
For pain and fever in CHILDREN: Stop use and ask a doctor if fever gets worse or lasts more than 3 days, pain gets worse or lasts more than 5 days, or redness or swelling is present or any new symptoms appear.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen Controlled-Release Tablets while you are pregnant. Acetaminophen Controlled-Release Tablets is found in breast milk. If you are or will be breast-feeding while you use Acetaminophen Controlled-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Acetaminophen Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; unusual fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.

Proper storage of Acetaminophen Controlled-Release Tablets:

Store Acetaminophen Controlled-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen Controlled-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Acetaminophen Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Acetaminophen Controlled-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Acetaminophen Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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