What is the most important information I should know about codeine, phenylephrine, and promethazine?
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Tell your doctor about all of your medical conditions before you start taking this medication. You should not use this medication if you are allergic to codeine, phenylephrine, or promethazine, or if you have high blood pressure, a blood vessel disorder, or asthma. |
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Do not give this medication to a child younger than 6 years old. |
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Do not use this medication if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. |
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Codeine may be habit-forming and should be used only by the person it was prescribed for. Never share codeine, phenylephrine, and promethazine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. |
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There are many other drugs that can interact with codeine, phenylephrine, and promethazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. |
What is codeine, phenylephrine, and promethazine?
Codeine is a narcotic. It is a pain reliever and a cough suppressant.
Promethazine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of codeine, phenylephrine, and promethazine is 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?
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You should not use this medication if you are allergic to codeine, phenylephrine, or promethazine, or if you have high blood pressure, a blood vessel disorder, or asthma. |
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Do not give this medication to a child younger than 6 years old. |
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Do not use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. |
To make sure you can safely take codeine, phenylephreine, and promethazine, tell your doctor if you have any of these other conditions:
- sleep apnea (breathing stops during sleep);
- chronic obstructive pulmonary disease (COPD);
- glaucoma;
- epilepsy or other seizure disorder;
- stomach ulcer, intestinal disorder, or digestive obstruction;
- recent stomach or urinary tract surgery;
- a weak immune system;
- Addison's disease;
- diabetes;
- a thyroid disorder;
- enlarged prostate, problems with urination;
- heart disease, poor circulation;
- liver or kidney disease; or
- a head injury or brain tumor.
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Codeine may be habit-forming and should be used only by the person it was prescribed for. Never share codeine, phenylephrine, and promethazine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. |
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FDA pregnancy category C. It is not known whether this medicine will harm an unborn baby. Codeine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. |
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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. Do not use this medication without telling your doctor if you are breast-feeding a baby. |
How should I take codeine, phenylephrine, and promethazine?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. 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.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using codeine, phenylephrine, and promethazine.
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Store at room temperature away from moisture, heat, and light. |
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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?
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?
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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medication may fatal. |
Overdose symptoms include severe drowsiness, pinpoint pupils, cold or clammy skin, limp or stiff muscles, shallow breathing, slow heart rate, and fainting.
What are the possible side effects of codeine, phenylephrine, and promethazine?
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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. |
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Stop using this medication and call your doctor at once if you have any of these serious side effects: |
- restless muscle movements in your eyes, tongue, jaw, or neck, tremor (uncontrolled shaking);
- weak or shallow breathing, feeling like you might pass out;
- fast, slow, or pounding heartbeats;
- confusion, agitation, hallucinations, nightmares, seizure (convulsions);
- jaundice (yellowing of the skin or eyes);
- pale skin, easy bruising or bleeding, weakness;
- urinating less than usual or not at all; or
- fever, stiff muscles, sweating, fast or uneven heartbeats, rapid breathing.
Less serious side effects may include:
- dizziness, drowsiness;
- feeling restless, nervous, or anxious;
- blurred vision, ringing in your ears;
- constipation, mild nausea or vomiting;
- warmth, redness, or tingly feeling under your skin;
- itching, increased sweating; or
- sleep problems (insomnia).
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?
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Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by codeine, phenylephrine, and promethazine. |
Many drugs can interact with codeine, phenylephrine, and promethazine. Below is just a partial list. Tell your doctor if you are using:
- atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
- a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva);
- glycopyrrolate (Robinul);
- mepenzolate (Cantil);
- bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
- irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine);
- ergot medicine such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine);
- an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), nortriptyline (Pamelor), and others; or
- a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others.
This list is not complete and other drugs may interact with codeine, phenylephrine, and promethazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
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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