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 codeine, phenylephrine, promethazine, or a phenothiazine medicine. Do not use it if you have asthma, high blood pressure, or blood vessel problems. This medicine is not meant for use in children younger than 6 years. Serious breathing problems and deaths have occurred when children have been given codeine.

How to Use This Medicine:
Syrup

• 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.
• This medicine is not for long-term use.
• 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.

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

• Do not use this medicine together with a MAO inhibitor.
• Some foods and medicines can affect how codeine/phenylephrine/promethazine works. Tell your doctor if you are using the following:
  
  • amphetamines
  • anticholinergics
  • atropine
  • epinephrine
  • ergot medicines
  • phenylpropanolamine
  • propranolol
  • medicine to treat depression
• Alcohol, allergy medicine, 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:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, Addison disease, bone marrow problems, breathing problems (such as COPD, sleep apnea), diabetes, enlarged prostate, heart or blood vessel problems, stomach or bowel problems (such as ulcers, ulcerative colitis), thyroid problems, or a history of head injury or seizures. Tell your doctor if you have glaucoma, you recently had stomach or urinary tract surgery, or you have been addicted to alcohol or drugs.
• Do not breastfeed while you are using this medicine, unless you have your doctor's permission to do so.
• This medicine may cause the following problems:
  
  • Respiratory depression
  • Neuroleptic malignant syndrome (NMS)
• This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• 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.
• 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, or yellow skin or eyes
• Extreme dizziness, drowsiness, or weakness
• Fever, sweating, confusion, uneven heartbeat, muscle stiffness
• Lightheadedness, dizziness, or fainting
• Trouble breathing, slow heartbeat or breathing, and cold, clammy skin

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

• Constipation
• 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