What is the most important information I should know about codeine, phenylephrine, and promethazine?
Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
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.
This medicine should not be used to treat cold or flu symptoms in anyone younger than 6 years old, and should not be used as a pain medicine in children younger than 12 or anyone under 18 who recently had surgery to remove the tonsils or adenoids.
Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
What is codeine, phenylephrine, and promethazine?
Codeine is a narcotic. It is a pain reliever and a cough suppressant.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
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.
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; or
- blood circulation problems.
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.
This medicine should not be used to treat cold or flu symptoms in anyone younger than 6 years old.
Codeine, phenylephrine, and promethazine should not be used as a pain medicine in children younger than 12 or anyone under 18 who recently had surgery to remove the tonsils or adenoids.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
- chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
- drug or alcohol addiction;
- a seizure disorder, head injury, or a brain tumor;
- stomach problems;
- severe or ongoing cough;
- diabetes;
- a thyroid disorder;
- heart disease;
- a blood cell disorder;
- glaucoma;
- Addison's disease (an adrenal gland disorder);
- enlarged prostate, problems with urination;
- liver or kidney disease; or
- surgery (recent or planned).
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.
Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby. Promethazine may slow breast milk production.
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.
You should not use antihistamine medication to make a child sleepy.
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.
Do not take for longer than 7 days in a row. Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.
If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you have used a cough or cold medicine in the past few days.
Store at room temperature away from moisture, heat, and light. Do not freeze.
Keep track of your medicine. 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 could occur.
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.
Avoid exposure to sunlight or tanning beds. This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
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:
- noisy breathing, sighing, shallow breathing;
- a slow heart rate or weak pulse;
- severe drowsiness;
- uncontrolled muscle movements;
- a light-headed feeling, like you might pass out;
- confusion, agitation, nightmares, hallucinations, seizure (convulsions);
- severe constipation, stomach pain;
- fast or pounding heartbeats;
- problems with speech, thinking, or memory;
- little or no urination;
-
increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
-
severe nervous system reaction --very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Common side effects may include:
- drowsiness, confusion;
- dry mouth, nose, or throat;
- nausea, vomiting;
- trouble breathing; or
- fast heartbeats, feeling restless.
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 codeine, phenylephrine, and promethazine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a 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:
- medicine to treat mental illness;
- medicine to treat a stomach or intestinal disorder; or
- cold or allergy medicine that contains an antihistamine.
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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