When This Medicine Should Not Be Used:
Do not use this medicine if you have had an allergic reaction to codeine, promethazine, or similar medicines (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, Trilafon®). Do not use this medicine to treat asthma or similar breathing problems. Do not give this medicine to a child younger than 6 years old. Serious breathing problems and deaths have occurred when children have been given medicine that contains codeine.

How to Use This Medicine:
Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, 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 to treat depression (such as amitriptyline, nortriptyline, Elavil®), or an MAO inhibitor (such as Eldepryl®, Marplan®, Nardil®, Parnate®). Tell your doctor if you are also using medicine to treat incontinence, or other medicine that can cause dry mouth or constipation (such as atropine, dicyclomine, glycopyrrolate, scopolamine, Bentyl®, Robinul®, Transderm Scop®).
• Alcohol, narcotic pain relievers, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you drink alcohol or use other medicine that makes you sleepy or lightheaded.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bone marrow problems, heart or blood vessel disease, lung or breathing problems (such as sleep apnea or asthma), stomach or bowel problems (such as blockage, ulcerative colitis, ulcers), or a history of seizures or allergies. Tell your doctor if you have Addison disease, diabetes, glaucoma, enlarged prostate, trouble urinating, thyroid problems, a recent surgery, or a history of head injury. Tell your doctor if you have been addicted to alcohol or drugs.
• 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.
• If you think you or someone else may have taken too much of this medicine, get emergency help at once. Signs of an overdose include seizure; extreme sleepiness; passing out; trouble breathing; uneven, fast, slow, or shallow breathing; nausea; vomiting; confusion; or pinpoint pupils of the eyes.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous until you know how this medicine affects you. You may also feel lightheaded when getting up suddenly from a lying or sitting position, so stand up slowly.
• 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 cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• 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 make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Call your doctor if your symptoms do not improve or if they get worse.

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
• Extreme sleepiness or confusion
• Fast, slow, or pounding heartbeat
• Fever, sweating, confusion, uneven heartbeat, muscle stiffness
• Lightheadedness or fainting
• Muscle movement you cannot control
• Seizures or tremors
• Trouble breathing, shallow breathing, blue lips or nails

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

• Constipation, dry mouth, nausea, vomiting, diarrhea
• Mild dizziness or drowsiness

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