When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to codeine.

How to Use This Medicine:
Tablet, Liquid

• Your doctor will tell you how much of this medicine to take and how often. Do not take more medicine or take it more often than your doctor tells you to.
• Measure the oral liquid medicine with a marked measuring spoon or medicine cup.
• 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.

• Make sure your doctor knows if you are also using medicine for diarrhea, nausea, or high blood pressure, or if you use metoclopramide (Reglan®), hydroxyzine (Atarax®), naltrexone (ReVia®), MAO inhibitors (Eldepryl®, Marplan®, Nardil®, Parnate®) diuretics (water pills), or other pain medicines.
• Avoid using any other medicines that make you sleepy (such as sleeping pills, cold and allergy medicine, or sedatives).
• Do not drink alcohol while you are taking this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have asthma or other breathing problems, diarrhea caused by poisons or other medicines, liver or kidney disease, inflammatory bowel disease, prostate problems, underactive thyroid, or a history of drug dependence or alcoholism.
• 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.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not take more than your prescribed dose. Call your doctor for instructions.
• Using too much of this medicine can cause serious side effects or even death. Symptoms of an overdose include: Extreme dizziness or weakness, shortness of breath, slow heartbeat, seizures, and cold, clammy skin.
• Do not stop using this medicine suddenly without asking your doctor. You may need to take less and less before stopping it completely.
• 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:

• Allergic reaction: Itching or hives, swelling in face or hands, swelling or tingling in the mouth or throat, tightness in chest, trouble breathing
• Hallucinations or unusual thoughts

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

• Constipation
• Lightheadedness
• Nausea or vomiting
• Sleepiness

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