codeine, phenylephrine, and promethazine

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Pronunciation: KOE deen, FEN il EFF rin, and pro METH a zeen

Brand: Promethazine VC with Codeine

What is the most important information I should know about codeine, phenylephrine, and promethazine?

You should not use this medicine if you have asthma, pneumonia or other lung problems, high blood pressure, blood circulation problems, or if you have used an MAO inhibitor in the past 14 days.

Codeine and promethazine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Codeine may also be habit-forming. Never share this medicine with another person. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids. Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

This medicine should not be given to a child younger than 2 years old. Promethazine can cause severe breathing problems or death in very young children.

What is codeine, phenylephrine, and promethazine?

Codeine is a narcotic. It is a pain reliever and a cough suppressant.

Promethazine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Codeine, phenylephrine, and promethazine is a combination medicine used to treat cold or allergy symptoms such as stuffy nose, sneezing, and cough.

Codeine, phenylephrine, and promethazine may also be used for purposes not listed in this medication guide.

What should I discuss with my doctor before taking codeine, phenylephrine, and promethazine?

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use codeine, phenylephrine, and promethazine if you are allergic to it, or if you have:

  • asthma, pneumonia, or other lung problems;
  • high blood pressure;
  • blood circulation problems; or
  • if you are allergic to a medicine similar to promethazine, such as chlorpromazine, fluphenazine, perphenazine, prochlorperazine, thioridazine, or trifluoperazine.

This medicine should not be given to a child younger than 2 years old. Promethazine can cause severe breathing problems or death in very young children. Always ask a doctor before giving this medicine to a child of any age. Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

To make sure this medicine is safe for you, tell your doctor if you have:

  • sleep apnea (breathing stops during sleep);
  • heart disease;
  • a fever and cough with mucus;
  • bone marrow suppression;
  • a thyroid disorder;
  • diabetes;
  • glaucoma;
  • enlarged prostate, problems with urination;
  • stomach ulcer or intestinal problems;
  • liver or kidney disease; or
  • a seizure disorder, or history of a head injury or brain tumor.

It is not known whether this medicine will harm an unborn baby. If you use codeine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Antihistamines may also slow breast milk production. Do not use this medicine without telling your doctor if you are breast-feeding a baby.

How should I take codeine, phenylephrine, and promethazine?

Follow all directions on your prescription label. Codeine and promethazine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve within 5 days of using this medicine.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture, heat, and light. Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medication may fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms include severe drowsiness, cold or clammy skin, pinpoint pupils, limp or stiff muscles, shallow breathing, slow heart rate, and fainting.

What should I avoid while taking codeine, phenylephrine, and promethazine?

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol while you are taking medicine that contains codeine. Dangerous side effects or death can occur when alcohol is combined with a narcotic medicine.

Ask a doctor or pharmacist before using any cold, cough, or sleep medication. Many combination medicines contain antihistamines, decongestants, or cough suppressants. Taking certain products together can cause you to get too much of these medicines.

What are the possible side effects of codeine, phenylephrine, and promethazine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Stop taking this medicine and call your doctor at once if you have:

  • uncontrolled muscle movements;
  • weak or shallow breathing;
  • confusion, agitation, nightmares, hallucinations, seizure (convulsions);
  • a light-headed feeling, like you might pass out;
  • fast, slow, or pounding heartbeats;
  • little or no urination;
  • jaundice (yellowing of the skin or eyes);
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or
  • easy bruising or bleeding.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

Common side effects may include:

  • headache, dizziness, drowsiness, weakness;
  • sleep problems (insomnia), nervousness;
  • flushing (warmth, redness, or tingly feeling);
  • nausea, vomiting, constipation, diarrhea;
  • itching, sweating; or
  • dry mouth, stuffy nose, double vision, ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect codeine, phenylephrine, and promethazine?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking codeine, phenylephrine, and promethazine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • diet pills, stimulants, or ADHD medication;
  • bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
  • bronchodilators such as aclidinium, ipratropium, tiotropium, or umeclidinium;
  • cold or allergy medicine that contains an antihistamine;
  • medication for Parkinson's disease; or
  • medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome.

This list is not complete. Other drugs may interact with codeine, phenylephrine, and promethazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about codeine, phenylephrine, and promethazine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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