Phenylephrine/ dextromethorphan/ guaifenesin capsules

Generic Name: phenylephrine/dextromethorphan/guaifenesin (FEN-il-EF-rin/DEX-troe-meth-OR-fan/gwye-FEN-e-sin)
Brand Name: Giltuss TR

Phenylephrine/ dextromethorphan/ guaifenesin capsules is used for:

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

Phenylephrine/dextromethorphan/guaifenesin capsules is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The expectorant works by loosening mucus and lung secretions in the chest, making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use phenylephrine/ dextromethorphan/ guaifenesin capsules if:

  • you are allergic to any ingredient in phenylephrine/dextromethorphan/guaifenesin capsules
  • you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
  • you take droxidopa or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

Before using phenylephrine/ dextromethorphan/ guaifenesin capsules:

Some medical conditions may interact with phenylephrine/dextromethorphan/guaifenesin capsules. 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 history of glaucoma or increased pressure in the eye, enlarged prostate gland or other prostate problems, heart problems (eg, fast, slow, or irregular heartbeat; heart disease), diabetes, high blood pressure, blood vessel problems, adrenal gland problems (eg, pheochromocytoma), mental or mood problems (eg, depression), trouble sleeping, an overactive thyroid, seizures, or stroke
  • if you have a history of asthma or other breathing problems, chronic cough, lung problems (eg, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), sleep apnea, or if your cough occurs with large amounts of mucus
  • if you are in poor health or are very overweight
  • if you take medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with phenylephrine/dextromethorphan/guaifenesin capsules. 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), furazolidone, linezolid, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of phenylephrine/dextromethorphan/guaifenesin capsules's side effects
  • Bromocriptine because the risk of its side effects may be increased by phenylephrine/dextromethorphan/guaifenesin capsules
  • Guanadrel, guanethidine, mecamylamine, medicines for high blood pressure, methyldopa, or reserpine because their effectiveness may be decreased by phenylephrine/dextromethorphan/guaifenesin capsules

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

Use phenylephrine/dextromethorphan/guaifenesin capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take phenylephrine/dextromethorphan/guaifenesin capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Take phenylephrine/dextromethorphan/guaifenesin capsules with a full glass of water (8 oz/240 mL).
  • Drink plenty of water while taking phenylephrine/dextromethorphan/guaifenesin capsules.
  • If you miss a dose of phenylephrine/dextromethorphan/guaifenesin capsules 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 phenylephrine/dextromethorphan/guaifenesin capsules.

Important safety information:

  • Phenylephrine/dextromethorphan/guaifenesin capsules may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use phenylephrine/dextromethorphan/guaifenesin capsules 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 phenylephrine/dextromethorphan/guaifenesin capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not take appetite suppressants while you are taking phenylephrine/dextromethorphan/guaifenesin capsules without checking with your doctor.
  • Before you start any new medicine, check the label to see if it has a decongestant, cough suppressant, or an expectorant 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 to 7 days or if they get worse, check with your doctor or pharmacist.
  • Do not use phenylephrine/dextromethorphan/guaifenesin capsules 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.
  • Phenylephrine/dextromethorphan/guaifenesin capsules may interfere with certain lab tests. Be sure that your doctor and lab personnel know you are taking phenylephrine/dextromethorphan/guaifenesin capsules.
  • Tell your doctor or dentist that you take phenylephrine/dextromethorphan/guaifenesin capsules before you receive any medical or dental care, emergency care, or surgery.
  • Use phenylephrine/dextromethorphan/guaifenesin capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.
  • Phenylephrine/dextromethorphan/guaifenesin capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using phenylephrine/dextromethorphan/guaifenesin capsules while you are pregnant. Phenylephrine/dextromethorphan/guaifenesin capsules may be found in breast milk. Do not breast-feed while taking phenylephrine/dextromethorphan/guaifenesin capsules.

Possible side effects of phenylephrine/ dextromethorphan/ guaifenesin capsules:

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:

Diarrhea; dizziness; drowsiness; excitability; headache; irritability; nausea; stomach upset; 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); confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, anxiety, nervousness); paleness; persistent trouble sleeping; restlessness; seizures; severe or persistent dizziness, drowsiness, headache, or lightheadedness; tremor.

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; difficulty urinating; fast or shallow breathing; hallucinations; paleness; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of phenylephrine/dextromethorphan/guaifenesin capsules:

Store phenylephrine/dextromethorphan/guaifenesin capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep phenylephrine/dextromethorphan/guaifenesin capsules out of the reach of children and away from pets.

General information:

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

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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