Pseudoephedrine/ codeine/ guaifenesin Syrup

Generic Name: codeine/guaifenesin/pseudoephedrine (KOE-deen/gwye-FEN-e-sin/SOO-doe-e-FED-rin)
Brand Name: Examples include Mytussin DAC and Robitussin DAC

Some children have had serious and sometimes fatal breathing problems when using codeine after surgery to remove tonsils or adenoids. Talk with your doctor for more information.


Pseudoephedrine/ codeine/ guaifenesin Syrup is used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/codeine/guaifenesin Syrup is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive.

Do NOT use pseudoephedrine/ codeine/ guaifenesin Syrup if:

  • you are allergic to any ingredient in pseudoephedrine/codeine/guaifenesin Syrup or any other codeine- or morphine-related medicine (eg, oxycodone)
  • you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
  • you are having an asthma attack
  • you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
  • the patient is a child and has just had surgery to remove tonsils or adenoids

Contact your doctor or health care provider right away if any of these apply to you.

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Before using pseudoephedrine/ codeine/ guaifenesin Syrup:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, hydrocodone, dihydrocodeine, oxycodone)
  • if you have a history of glaucoma; an enlarged prostate gland or other prostate problems; heart problems; diabetes; high blood pressure; blood vessel problems; stroke; liver or kidney problems; blockage of the stomach, bowel, or bladder; adrenal gland problems; or thyroid problems
  • if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery
  • if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if you have a cough that occurs with large amounts of mucus
  • if you have a fever, severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)
  • if you have very poor health or a history of alcohol abuse, other substance abuse, or suicidal thoughts or actions
  • if you are taking medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with pseudoephedrine/codeine/guaifenesin Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of pseudoephedrine/codeine/guaifenesin Syrup's side effects
  • Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease pseudoephedrine/codeine/guaifenesin Syrup's effectiveness
  • Bromocriptine or sodium oxybate (GHB) because the risk of their side effects may be increased by pseudoephedrine/codeine/guaifenesin Syrup
  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by pseudoephedrine/codeine/guaifenesin Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if pseudoephedrine/codeine/guaifenesin Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use pseudoephedrine/ codeine/ guaifenesin Syrup:

  • Take pseudoephedrine/codeine/guaifenesin Syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Drink plenty of water while taking pseudoephedrine/codeine/guaifenesin Syrup.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you miss a dose of pseudoephedrine/codeine/guaifenesin Syrup, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use pseudoephedrine/codeine/guaifenesin Syrup.

Important safety information:

  • Pseudoephedrine/codeine/guaifenesin Syrup may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use pseudoephedrine/codeine/guaifenesin Syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using pseudoephedrine/codeine/guaifenesin Syrup; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Pseudoephedrine/codeine/guaifenesin Syrup may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not take diet or appetite control medicines while you are taking pseudoephedrine/codeine/guaifenesin Syrup without checking with your doctor.
  • Pseudoephedrine/codeine/guaifenesin Syrup has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • If your symptoms do not get better within 5 days, if they get worse, or if they go away and then come back, check with your doctor.
  • If your symptoms occur along with fever, rash, or persistent headache, contact your doctor.
  • Do not use pseudoephedrine/codeine/guaifenesin Syrup for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
  • Pseudoephedrine/codeine/guaifenesin Syrup may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to pseudoephedrine/codeine/guaifenesin Syrup. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Pseudoephedrine/codeine/guaifenesin Syrup may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking pseudoephedrine/codeine/guaifenesin Syrup.
  • Tell your doctor or dentist that you take pseudoephedrine/codeine/guaifenesin Syrup before you receive any medical or dental care, emergency care, or surgery.
  • Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
  • Use pseudoephedrine/codeine/guaifenesin Syrup with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.
  • Caution is advised when using pseudoephedrine/codeine/guaifenesin Syrup in CHILDREN; they may be more sensitive to its effects, especially excitability.
  • Pseudoephedrine/codeine/guaifenesin Syrup should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using pseudoephedrine/codeine/guaifenesin Syrup while you are pregnant. Pseudoephedrine/codeine/guaifenesin Syrup is found in breast milk. Do not breast-feed while taking pseudoephedrine/codeine/guaifenesin Syrup.

Possible side effects of pseudoephedrine/ codeine/ guaifenesin Syrup:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow or rapid breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of pseudoephedrine/codeine/guaifenesin Syrup:

Store pseudoephedrine/codeine/guaifenesin Syrup at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep pseudoephedrine/codeine/guaifenesin Syrup out of the reach of children and away from pets.

General information:

  • If you have any questions about pseudoephedrine/codeine/guaifenesin Syrup, please talk with your doctor, pharmacist, or other health care provider.
  • Pseudoephedrine/codeine/guaifenesin Syrup is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take pseudoephedrine/codeine/guaifenesin Syrup or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pseudoephedrine/codeine/guaifenesin Syrup. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pseudoephedrine/codeine/guaifenesin Syrup. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using pseudoephedrine/codeine/guaifenesin Syrup.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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