What is the most important information I should know about codeine, guaifenesin, and pseudoephedrine?
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.
This medicine is not for use in anyone under 18.
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, guaifenesin, and pseudoephedrine?
Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.
Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Codeine, guaifenesin, and pseudoephedrine is a combination medicine used to treat cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.
This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.
Codeine, guaifenesin, and pseudoephedrine may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking codeine, guaifenesin, and pseudoephedrine?
You should not use this medicine if you are allergic to codeine, guaifenesin, or pseudoephedrine.
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.
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.
Do not give this medicine to anyone younger than 18 years old.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
- asthma, COPD, or other breathing disorders;
- a cough with mucus;
- heart disease, high blood pressure;
- a stroke, or a blood vessel disorder;
- drug or alcohol addiction;
- liver or kidney disease;
- a blockage in your stomach or intestines;
- a head injury, brain tumor, or seizure;
- Addison's disease (an adrenal gland disorder);
- a thyroid disorder; or
- enlarged prostate and urination problems.
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.
How should I take codeine, guaifenesin, and pseudoephedrine?
Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use codeine, guaifenesin, and pseudoephedrine 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.
Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.
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 if you have taken a cough or cold medicine within the past few days.
Store at room temperature away from moisture and heat.
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. A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, confusion, hallucinations, cold and clammy skin, pinpoint pupils, and fainting.
What should I avoid while taking codeine, guaifenesin, and pseudoephedrine?
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 other cold, allergy, or cough medicine. Many combination medicines contain decongestants or cough suppressants. Taking certain products together can cause you to get too much of a certain drug.
What are the possible side effects of codeine, guaifenesin, and pseudoephedrine?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medications, codeine can slow your breathing. Death may occur if breathing becomes too weak.
A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Stop taking this medicine and call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing;
- severe drowsiness, hallucinations;
- fast, slow, or uneven heart rate;
- a seizure;
- nervousness, tremors; or
- little or no urination.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Common side effects may include:
- dizziness, drowsiness, weakness;
- nausea, constipation;
- sleep problems (insomnia); or
- feeling nervous, anxious, or 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, guaifenesin, and pseudoephedrine?
Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.
Taking codeine, guaifenesin, and pseudoephedrine 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.
Where can I get more information?
Your pharmacist can provide more information about codeine, guaifenesin, and pseudoephedrine.
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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2023 Cerner Multum, Inc. Version: 4.01. Revision date: 1/15/2018.