When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to acetaminophen or salicylates, or if you are taking other medicine that contains acetaminophen.

How to Use This Medicine:
Tablet

• This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods can affect how this medicine works. Tell your doctor if you are taking any of the following:
  
  • A blood thinner, such as warfarin
  • Combination medicines that contain acetaminophen or aspirin
  • Other medicines that contain caffeine, such as some diet pills and pain relievers
  • Phenobarbital
• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and alcohol can increase this risk. If you regularly drink 3 or more alcoholic drinks every day, do not take any medicines that contain acetaminophen without asking your doctor. A drink of alcohol is 12 ounces of beer, 4 ounces of wine, or 1 ounce of liquor.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• Tell your doctor if you have liver or kidney disease, a stomach ulcer, asthma, or problems with your blood.
• Aspirin can cause a rare but serious illness called Reye syndrome in children and teenagers. Do not give this medicine to a child or teenager younger than 18 years, unless your doctor has told you to. If the child or teenager has behavior changes along with nausea and vomiting, call his doctor right away.
• This medicine may make you dizzy or drowsy. Do not drive or use machines if you are not alert.
• Do not have foods, drinks, or other medicines that contain caffeine. Too much caffeine can cause unwanted side effects.
• Carefully check the labels of all other medicines you are taking to be sure they do not contain acetaminophen or aspirin. Too much of these medicines can cause serious side effects.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• If your symptoms do not improve within 10 days, or if they get worse, call your doctor.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Dark urine or pale stools, nausea, vomiting, loss of appetite, or stomach pain, yellow skin or eyes
• Fast or uneven heartbeat
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• Nervousness, irritability, or trouble sleeping
• Ringing in your ears, or loss of hearing
• Unusual tiredness or drowsiness
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088