Codeine (KOE-deen), Promethazine (proe-METH-a-zeen)

Treats cough and runny or stuffy nose caused by flu, allergies, or the common cold. This medicine contains a narcotic cough suppressant.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Oral liquid: Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Drink plenty of liquids to help avoid constipation.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• 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.
• Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website:www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm 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.

• Some medicines can affect how promethazine/codeine works. Tell your doctor if you are using medicine to treat depression or anxiety (including MAO inhibitor).
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor 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.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Neuroleptic malignant syndrome
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• 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.
• 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
• Blue lips or nails, trouble breathing
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, seizures
• Fast or pounding heartbeat
• Fever, confusion, muscle stiffness
• Lightheadedness, dizziness, fainting
• Muscle movement you cannot control

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

• Mild constipation, dry mouth, nausea, vomiting, diarrhea
• Mild drowsiness or 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