Treats pain.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Your doctor will tell you how much medicine to take and how often.
• Take with food and a large glass of water.
• Drink plenty of liquids to help avoid constipation.

If a dose is missed:

• Take the missed dose as soon as possible.
• Skip the missed dose if it is almost time for your next regular dose.
• You should not use two doses at the same time.

How to Store and Dispose of This Medicine:

• Store at room temperature, away from heat, direct light, and moisture.
• Keep all medicine out of the reach of children.

Drugs and Foods to Avoid:

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

• Avoid drinking alcohol.
• Check with your doctor before taking this medicine if you are currently taking Coumadin®, or medicines that can make you sleepy such as sleeping pills, muscle relaxants, tranquilizers, cough and cold medicines, or other pain-killers.

Warnings While Using This Medicine:

• If you are pregnant or breastfeeding, talk to your doctor before taking this medicine.
• Make sure your doctor knows if you have any other medical problems, such as colitis, emphysema, asthma, hepatitis or other liver diseases, heart, lung, or blood disease, or stomach ulcer.
• This medicine can be habit-forming. You should not use more than the prescribed amount.
• If you have taken this medicine for several weeks, do not stop taking it suddenly without asking your doctor. You may need to take smaller and smaller doses before completely stopping this medicine.
• This medicine may cause drowsiness. If it does, be careful while driving a car or using machinery.
• 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:

• Black or tarry stools
• Trouble urinating
• Ringing in ears
• Very fast, slow, or pounding heartbeat
• Trouble breathing
• Severe stomach pain, vomiting up material that looks like coffee grounds
• Severe drowsiness, confusion
• Changes in behavior

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

• Dizziness or drowsiness
• Tiredness or weakness
• Nausea or vomiting, indigestion
• Constipation
• Dry mouth
• Nervousness

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