When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to acetaminophen (Tylenol®), aspirin, caffeine, codeine, or butalbital. You should not use this medicine if you have had an allergic reaction to related medicines such as phenobarbital, pentobarbital, or arthritis medicines. You should not use this medicine if you have stomach ulcers, a bleeding disorder (hemophilia), or porphyria (an inherited disease).

How to Use This Medicine:
Capsule, Tablet, Solution

• Your doctor will tell you how much medicine to use. Do not use more than directed. If this medicine contains acetaminophen, it is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• If this medicine upsets your stomach, you may take it with food or milk.
• This medicine works best if you take it at the first sign of headache or pain.
• Drink plenty of liquids to help avoid constipation.
• If you have taken large amounts of this medicine or have taken it regularly for several weeks, do not suddenly stop taking it without talking to your doctor.
• This medicine is not for long-term use.

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

• Make sure your doctor knows if you are also using a monoamine oxidase inhibitor (MAOI) medicine, such as Eldepryl®, Marplan®, Nardil®, or Parnate®.
• If this medicine contains aspirin, be sure to tell your doctor if you are using a blood thinner such as warfarin (Coumadin®).
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine. If this medicine contains acetaminophen, it can damage your liver and drinking alcohol can increase this risk. If you regularly drink 3 or more alcoholic drinks every day, do not take acetaminophen without asking your doctor.
• Many combination medicines contain acetaminophen or aspirin. Carefully check the labels of all other medicines you are using to be sure they do not contain acetaminophen or aspirin.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you have asthma, other lung problems, heart disease, kidney disease, or liver disease.
• Make sure your doctor knows if you have a head injury or any problems with your brain. Tell your doctor if you have stomach problems, hypothyroidism (underactive thyroid gland), Addison's disease (adrenal gland problems), urethral stricture (problems with your urinary tract), or prostate problems.
• If this medicine contains aspirin, it should not be taken by children or teenagers with symptoms of the flu or other viral infection.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• When a mother is breastfeeding and takes codeine, there is a very small chance that this medicine could cause serious side effects in the baby. This is because codeine works differently in a few women, so their breastmilk contains too much medicine. If you take codeine, be alert for these signs of overdose in your nursing baby: sleeping more than usual, trouble breastfeeding, trouble breathing, or being limp and weak. Call the baby's doctor right away if you think there is a problem. If you cannot talk to the doctor, take the baby to the emergency room or call 911.

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
• Black or tarry stools.
• Blistering, peeling, red skin rash.
• Dark-colored urine or pale stools.
• Fainting.
• Fever.
• Seizures.
• Severe confusion, drowsiness, or muscle weakness.
• Severe nausea or vomiting, stomach pain, and increased sweating.
• Trouble breathing.
• Unusual bleeding, bruising, or weakness.
• Very fast heart beat.
• Yellowing of your skin or the whites of your eyes.

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

• Feeling "drunk."
• Feeling unusually confused, excited, or sad.
• Feeling unusually tired or sleepy.
• Headache, earache, or ringing in your ears.
• Increase in how much or how often you urinate.
• Lightheadedness.
• Nausea, vomiting, stomach pain, gassiness, or constipation.
• Skin redness or rash.
• Sweating more than usual.

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