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Chlorpheniramine/ codeine/ acetaminophen

Generic Name: chlorpheniramine/codeine/acetaminophen (KLOR-fen-IR-a-meen/KOE-deen/a-SEET-a-MIN-oh-fen)
Brand Name: Cotabflu

Chlorpheniramine/codeine/acetaminophen contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

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

Chlorpheniramine/ codeine/ acetaminophen is used for:

Treating symptoms of upper respiratory allergies and other conditions, such as cough, runny nose, pain, and fever. Chlorpheniramine/codeine/acetaminophen may also be used for other conditions as determined by your doctor.

Chlorpheniramine/codeine/acetaminophen is a narcotic cough suppressant, analgesic, and antihistamine combination. The cough suppressant works in the brain to help decrease the cough reflex. The analgesic works in the brain to reduce pain and fever. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing.

Do NOT use chlorpheniramine/ codeine/ acetaminophen if:

  • you are allergic to any ingredient in chlorpheniramine/codeine/acetaminophen
  • you are breast-feeding
  • you have severe or uncontrolled high blood pressure, severe heart blood vessel disease, an enlarged prostate, narrow-angle glaucoma, or a peptic ulcer
  • you are unable to urinate or 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.

Before using chlorpheniramine/ codeine/ acetaminophen:

Some medical conditions may interact with chlorpheniramine/codeine/acetaminophen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • 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 an allergic reaction to any other codeine- or morphine-related medicine (eg, oxycodone, dihydrocodeine, hydromorphone)
  • if you have a history of glaucoma or increased pressure in the eye; heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease); diabetes; high or low blood pressure; blood vessel problems (eg, in the brain, in the heart); adrenal gland problems (eg, Addison disease); prostate problems; stomach or bowel problems (eg, inflammatory bowel disease, ulcerative colitis, ulcers); seizures; stroke; liver problems (eg, hepatitis); kidney problems; thyroid problems; trouble sleeping; or recent stomach, bowel, or urinary surgery
  • if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing), or chronic cough, or if your cough occurs with large amounts of mucus
  • if you have severe drowsiness, increased pressure in the brain, an unusual growth in the brain (eg, tumor), a recent head or brain injury, or infection of the brain or nervous system
  • if you have difficulty urinating; low blood volume; a certain bowel problem (pseudomembranous colitis); stomach pain; constipation; a blockage of your bladder, stomach, or bowels; or poor health
  • if you are very overweight or are dehydrated
  • if you drink alcohol, or if you have a history of alcohol or drug abuse or dependence or of suicidal thoughts or behaviors

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

  • Anticoagulants (eg, warfarin) or isoniazid because the risk of bleeding or liver problems may be increased
  • Anticholinergics (eg, scopolamine) because a serious bowel motility problem (paralytic ileus) may occur
  • Cimetidine, furazolidone, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of chlorpheniramine/codeine/acetaminophen's side effects
  • Buprenorphine, naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease chlorpheniramine/codeine/acetaminophen's effectiveness
  • Medicines that may harm the liver (eg, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if chlorpheniramine/codeine/acetaminophen 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 chlorpheniramine/ codeine/ acetaminophen:

Use chlorpheniramine/codeine/acetaminophen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take chlorpheniramine/codeine/acetaminophen by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • If you miss a dose of chlorpheniramine/codeine/acetaminophen and you are taking it regularly, 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 chlorpheniramine/codeine/acetaminophen.

Important safety information:

  • Chlorpheniramine/codeine/acetaminophen may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use chlorpheniramine/codeine/acetaminophen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Chlorpheniramine/codeine/acetaminophen may cause dizziness, light-headedness, 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 drink alcohol while you are taking chlorpheniramine/codeine/acetaminophen.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking chlorpheniramine/codeine/acetaminophen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Chlorpheniramine/codeine/acetaminophen may cause or worsen constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking chlorpheniramine/codeine/acetaminophen, talk with your doctor or pharmacist.
  • Chlorpheniramine/codeine/acetaminophen may cause dry mouth. To help relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute. Ask your doctor or pharmacist if you have any questions.
  • Do NOT take more than the recommended dose, take more often than prescribed, or take for longer than prescribed without checking with your doctor.
  • Chlorpheniramine/codeine/acetaminophen may harm your liver. Your risk may be greater if you drink alcohol while you are taking chlorpheniramine/codeine/acetaminophen. Talk to your doctor before you take chlorpheniramine/codeine/acetaminophen or other fever reducers if you drink alcohol.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.
  • Chlorpheniramine/codeine/acetaminophen may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to chlorpheniramine/codeine/acetaminophen. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Chlorpheniramine/codeine/acetaminophen has acetaminophen, an antihistamine (chlorpheniramine), and a narcotic cough suppressant (codeine) in it. Before you start any new medicine, check the label to see if it has any of these medicines, other antihistamines, or other narcotic pain relievers or cough suppressants in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • If your symptoms do not get better within 7 days, if they come back, or if you develop a high fever, rash, or persistent headache, check with your doctor.
  • Chlorpheniramine/codeine/acetaminophen may interfere with skin allergy tests. If you are scheduled for a skin allergy test, talk to your doctor. You may need to stop taking chlorpheniramine/codeine/acetaminophen for a few days before the tests.
  • Tell your doctor or dentist that you take chlorpheniramine/codeine/acetaminophen before you receive any medical or dental care, emergency care, or surgery.
  • Use chlorpheniramine/codeine/acetaminophen with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, confusion, dizziness, drowsiness, dry mouth, excitability, and trouble urinating.
  • Caution is advised when using chlorpheniramine/codeine/acetaminophen in CHILDREN; they may be more sensitive to its effects, especially excitability.
  • Chlorpheniramine/codeine/acetaminophen should not be used in CHILDREN younger than 6 years; 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 taking chlorpheniramine/codeine/acetaminophen while you are pregnant. Chlorpheniramine/codeine/acetaminophen is found in breast milk. Do not breast-feed while taking chlorpheniramine/codeine/acetaminophen.

When used for long periods of time or at high doses, chlorpheniramine/codeine/acetaminophen may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if chlorpheniramine/codeine/acetaminophen stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking chlorpheniramine/codeine/acetaminophen. This is known as DEPENDENCE or addiction.

If you suddenly stop taking chlorpheniramine/codeine/acetaminophen, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping; and vomiting.

Possible side effects of chlorpheniramine/ codeine/ acetaminophen:

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; headache; light-headedness; mild dry mouth, throat, or nose; nausea; sweating; 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, throat, or tongue); changes in thinking or behavior; confusion; difficulty urinating or inability to urinate; excitability; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; flushing or redness of the face; hallucinations; involuntary muscle movements; mental or mood changes (eg, anxiety, fear, irritability, nervousness); persistent trouble sleeping; seizures; severe dry mouth, nose, or throat; severe or persistent dizziness, drowsiness, or light-headedness; shortness of breath; slow or shallow breathing; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

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 bluish skin or nails; blurred vision; cold and clammy skin; coma; confusion; decreased coordination; decreased pupil size; decreased urination; fainting; hallucinations; increased sweating; limp muscles; loss of consciousness; ringing in the ears; seizures; severe dizziness, drowsiness, or light-headedness; severe nausea or vomiting; sleeplessness; slow, difficult, or shallow breathing; slow heartbeat; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremors; unusual bruising or bleeding; unusual tiredness.

Proper storage of chlorpheniramine/codeine/acetaminophen:

Store chlorpheniramine/codeine/acetaminophen 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 chlorpheniramine/codeine/acetaminophen out of the reach of children and away from pets.

General information:

  • If you have any questions about chlorpheniramine/codeine/acetaminophen, please talk with your doctor, pharmacist, or other health care provider.
  • Chlorpheniramine/codeine/acetaminophen 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 chlorpheniramine/codeine/acetaminophen 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 chlorpheniramine/codeine/acetaminophen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to chlorpheniramine/codeine/acetaminophen. 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 chlorpheniramine/codeine/acetaminophen.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.