Acetaminophen/ dexbrompheniramine/ phenylephrine

Generic Name: acetaminophen/dexbrompheniramine/phenylephrine (a-SEET-a-MIN-oh-fen/dex-brome-fen-IR-a-meen/FEN-il-EF-rin)
Brand Name: Generic only. No brands available.

Acetaminophen/ dexbrompheniramine/ phenylephrine is used for:

Relieving symptoms of colds, hay fever, and allergies such as headache, sinus pain, nasal and sinus congestion, sneezing, watery eyes, runny nose, fever, and itching of the nose or throat. It may also be used for other conditions as determined by your doctor.

Acetaminophen/dexbrompheniramine/phenylephrine is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain. The antihistamine works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages.

Do NOT use acetaminophen/ dexbrompheniramine/ phenylephrine if:

  • you are allergic to any ingredient in acetaminophen/dexbrompheniramine/phenylephrine
  • you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
  • you are unable to urinate or are having an asthma attack

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

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Before using acetaminophen/ dexbrompheniramine/ phenylephrine:

Some medical conditions may interact with acetaminophen/dexbrompheniramine/phenylephrine. 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 a fast, slow, or irregular heartbeat
  • if you have a history of asthma; lung problems (eg, emphysema); heart problems; diabetes; difficulty urinating; an enlarged prostate or other prostate problems; glaucoma; high blood pressure; an overactive thyroid; liver problems (eg, hepatitis) or severe kidney problems; adrenal gland problems (eg, pheochromocytoma); sleep apnea; trouble sleeping; stomach problems; ulcers; seizures; blood vessel problems; stroke; or a blockage of your stomach, intestines, or bladder
  • if you drink more than 3 alcohol-containing drinks per day

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

  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the risk of acetaminophen/dexbrompheniramine/phenylephrine's side effects may be increased
  • Anticoagulants (eg, warfarin), bromocriptine, digoxin, droxidopa, or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by acetaminophen/dexbrompheniramine/phenylephrine
  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by acetaminophen/dexbrompheniramine/phenylephrine

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

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

  • Take acetaminophen/dexbrompheniramine/phenylephrine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • If you miss a dose of acetaminophen/dexbrompheniramine/phenylephrine 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 acetaminophen/dexbrompheniramine/phenylephrine.

Important safety information:

  • Acetaminophen/dexbrompheniramine/phenylephrine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use acetaminophen/dexbrompheniramine/phenylephrine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Avoid alcoholic drinks while you are using acetaminophen/dexbrompheniramine/phenylephrine. Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using acetaminophen/dexbrompheniramine/phenylephrine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not take more than the recommended dose of acetaminophen/dexbrompheniramine/phenylephrine. Doing so will not improve your condition faster and may increase your risk for side effects.
  • If your symptoms do not improve within 7 days, if they get worse, or if they occur with fever, rash, or persistent headache, check with your doctor
  • Acetaminophen/dexbrompheniramine/phenylephrine has acetaminophen, dexbrompheniramine, and phenylephrine in it. Before you start any new medicine, check the label to see if it has acetaminophen, dexbrompheniramine, or phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do not take diet or appetite control medicines while you are taking acetaminophen/dexbrompheniramine/phenylephrine without checking with your doctor.
  • Acetaminophen/dexbrompheniramine/phenylephrine may harm your liver. Your risk may be greater if you drink alcohol while you are using acetaminophen/dexbrompheniramine/phenylephrine. Talk to your doctor before you take acetaminophen/dexbrompheniramine/phenylephrine or other fever reducers if you drink more than 3 drinks with alcohol per day.
  • 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.
  • Acetaminophen/dexbrompheniramine/phenylephrine may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking acetaminophen/dexbrompheniramine/phenylephrine for a few days before the tests.
  • If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take acetaminophen/dexbrompheniramine/phenylephrine.
  • Use acetaminophen/dexbrompheniramine/phenylephrine with caution in the ELDERLY; they may be more sensitive to its effects.
  • Caution is advised when using acetaminophen/dexbrompheniramine/phenylephrine in CHILDREN; they may be more sensitive to its effects, especially excitability.
  • Do not use acetaminophen/dexbrompheniramine/phenylephrine in CHILDREN younger than 6 years old without checking with the child's doctor; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if acetaminophen/dexbrompheniramine/phenylephrine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using acetaminophen/dexbrompheniramine/phenylephrine while you are pregnant. Some of the ingredients in acetaminophen/dexbrompheniramine/phenylephrine are found in breast milk. If you are or will be breast-feeding while you use acetaminophen/dexbrompheniramine/phenylephrine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of acetaminophen/ dexbrompheniramine/ phenylephrine:

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:

Dizziness; drowsiness; dry mouth, nose, or throat; headache; nausea; nervousness; trouble sleeping.

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); chest pain; dark urine or pale stools; difficulty urinating; excessive sweating; fast or irregular heartbeat; frequent urination; hallucinations; pounding in the chest; rapid pulse; seizures; severe or persistent headache or dizziness; severe or persistent nervousness, restlessness, or trouble sleeping; stomach pain; tremors; unusual fatigue; yellowing of the skin or eyes.

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 fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sweating; tremors; trouble breathing; unusual drowsiness or dizziness; vomiting.

Proper storage of acetaminophen/dexbrompheniramine/phenylephrine:

Store acetaminophen/dexbrompheniramine/phenylephrine 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 acetaminophen/dexbrompheniramine/phenylephrine out of the reach of children and away from pets.

General information:

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

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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