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 codeine, or to other narcotic medicines.

How to Use This Medicine:
Capsule, Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You may take this medicine with food or milk if it upsets your stomach.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Drink plenty of liquids to help avoid constipation.
• 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. Keep the oral liquid in the refrigerator. Do not freeze.

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:
  
  • Depression medicine, such as citalopram, fluoxetine, sertraline
  • Phenothiazine medicine, such as prochlorperazine
  • Tranquilizer medicine, such as chlordiazepoxide
• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and alcohol can increase this risk. Do not take acetaminophen without asking your doctor if you have 3 or more drinks of alcohol every day.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, adrenal problems (such as Addison disease), asthma, or breathing problems (such as respiratory depression, sleep apnea). Tell your doctor if you have an enlarged prostate, trouble urinating, stomach problems, an underactive thyroid, or a history of head injury or brain damage. Tell your doctor if you had an allergic reaction to sulfites or if you have a history of drug or alcohol abuse.
• 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 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.
• If you take this medicine for more than a few weeks, do not stop taking it suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Get emergency help immediately if you think you may have taken too much of this medicine. Signs of an overdose include shallow breathing, fainting, confusion, nausea, vomiting, pinpoint pupils of the eyes, or pale or blue lips, fingernails, or skin.
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• 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.
• 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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme drowsiness or confusion
• Lightheadedness, dizziness, or fainting
• Seizures
• Trouble breathing, shallow breathing, blue lips or nails
• Unusual bleeding, bruising, or weakness

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

• Mild dizziness or drowsiness
• Mild nausea or vomiting, constipation
• Rash or itching skin

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