When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to codeine, aspirin, or pain and arthritis medicines (such as Motrin®, Advil®, Naprosyn®, Indocin® or Clinoril®)). Aspirin should not be given to children or teenagers with fever, chickenpox, or symptoms of the flu or virus infections unless approved by your child's doctor. You should not use this medicine if you have ulcers or any bleeding problems.

How to Use This Medicine:
Tablet

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

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.
• Make sure your doctor knows if you are taking any medicine that could make you sleepy, such as sleeping pills, cold and allergy medicine, tranquilizers, medicine to treat depression, or other strong pain killers.
• Tell your doctor if you are taking a blood thinner such as Coumadin®, steroids such as prednisone, or medicine for arthritis, diabetes, or gout.

Warnings While Using This Medicine:

• Talk with your doctor before taking if you are pregnant or breastfeeding or if you have asthma or other breathing problems, heart, liver or kidney disease, gout, seizures, or any stomach problems.
• This medicine can be habit-forming. You should not use more than your doctor ordered.
• If you have taken this medicine for several weeks, do not suddenly stop taking it. You may need to take smaller and smaller doses before completely stopping.
• Codeine can make you sleepy. Be careful if you are 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 breast milk 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:

• Severe stomach pain, vomiting blood, or vomit that looks like coffee grounds.
• Bloody stools.
• Extreme drowsiness or confusion.
• Trouble breathing.
• Rash or hives.
• Swelling of the face, throat, or lips.
• Ringing in the ears.

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

• Dizziness or drowsiness.
• Mild nausea or vomiting, or indigestion.
• Dry mouth.
• Constipation.
• 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