Acetaminophen/ dextromethorphan/ guaifenesin/ phenylephrine

Generic Name: acetaminophen/dextromethorphan/guaifenesin/phenylephrine (a-SEET-a-MIN-oh-fen/DEX-troe-meth-OR-fan/gwye-FEN-e-sin/FEN-il-EF-rin and a-SEET-a-MIN-oh-fen/DYE-fen-HYE-dra-meen/FEN-il-EF-rin)
Brand Name: Sudafed PE Day & Night Cold

Acetaminophen/ dextromethorphan/ guaifenesin/ phenylephrine is used for:

Relieving symptoms of fever, headache, pain, sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, sore throat, and cough due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Acetaminophen/dextromethorphan/guaifenesin/phenylephrine is an analgesic, antihistamine, cough suppressant, decongestant, and expectorant combination. The analgesic works in the brain to decrease pain and reduce fever. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to reduce a dry or unproductive cough. 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.

Do NOT use acetaminophen/ dextromethorphan/ guaifenesin/ phenylephrine if:

  • you are allergic to any ingredient in acetaminophen/dextromethorphan/guaifenesin/phenylephrine
  • 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
  • you are taking droxidopa, sodium oxybate (GHB), or you 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.

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Before using acetaminophen/ dextromethorphan/ guaifenesin/ phenylephrine:

Some medical conditions may interact with acetaminophen/dextromethorphan/guaifenesin/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 adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat), high blood pressure, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, or thyroid problems
  • if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea); chronic obstructive pulmonary disease (COPD); or if your cough occurs with large amounts of mucus
  • if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; liver problems; an enlarged prostate or other prostate problems; or trouble urinating
  • if you smoke, drink more than 3 alcohol-containing drinks per day, or have a history of alcohol abuse

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

  • Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat, or heart attack may be increased
  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of acetaminophen/dextromethorphan/guaifenesin/phenylephrine's side effects
  • Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by acetaminophen/dextromethorphan/guaifenesin/phenylephrine
  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by acetaminophen/dextromethorphan/guaifenesin/phenylephrine

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

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

  • Take acetaminophen/dextromethorphan/guaifenesin/phenylephrine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • This product contains 2 different tablets, one for the morning and one for the evening. Be sure you understand how to take acetaminophen/dextromethorphan/guaifenesin/phenylephrine. Check with your doctor or pharmacist if you are not sure which tablet to take in the morning and which to take in the evening.
  • If you miss a dose of acetaminophen/dextromethorphan/guaifenesin/phenylephrine, 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/dextromethorphan/guaifenesin/phenylephrine.

Important safety information:

  • Acetaminophen/dextromethorphan/guaifenesin/phenylephrine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use acetaminophen/dextromethorphan/guaifenesin/phenylephrine 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 acetaminophen/dextromethorphan/guaifenesin/phenylephrine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not take diet or appetite control medicines while you use acetaminophen/dextromethorphan/guaifenesin/phenylephrine unless your doctor tells you otherwise.
  • Acetaminophen/dextromethorphan/guaifenesin/phenylephrine contains acetaminophen, dextromethorphan, diphenhydramine, guaifenesin, and phenylephrine. Before you start any new medicine, check the label to see if it has any of these medicines in it. If it does or if you are not sure, check with your doctor or pharmacist.
  • Acetaminophen/dextromethorphan/guaifenesin/phenylephrine may harm your liver. Your risk may be greater if you drink alcohol while you are using acetaminophen/dextromethorphan/guaifenesin/phenylephrine, if you take more than the recommended dose, or if you are taking another medicine that contains acetaminophen. Talk to your doctor before you take acetaminophen/dextromethorphan/guaifenesin/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.
  • Do not use acetaminophen/dextromethorphan/guaifenesin/phenylephrine 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.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • If new symptoms occur; if cough occurs with persistent rash or headache; or if your symptoms go away and come back, do not get better within 7 days, or get worse, check with your doctor.
  • Contact your doctor if you have a sore throat that is severe; lasts more than 2 days; or occurs with a fever, rash, headache, nausea, or vomiting.
  • Contact your doctor if you have a fever that lasts for more than 3 days.
  • Acetaminophen/dextromethorphan/guaifenesin/phenylephrine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to acetaminophen/dextromethorphan/guaifenesin/phenylephrine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
  • Acetaminophen/dextromethorphan/guaifenesin/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/dextromethorphan/guaifenesin/phenylephrine for a few days before the tests.
  • Tell your doctor or dentist that you take acetaminophen/dextromethorphan/guaifenesin/phenylephrine before you receive any medical or dental care, emergency care, or surgery.
  • Use acetaminophen/dextromethorphan/guaifenesin/phenylephrine with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, nervousness, sleeplessness, and trouble urinating.
  • Caution is advised when using acetaminophen/dextromethorphan/guaifenesin/phenylephrine in CHILDREN; they may be more sensitive to its effects, especially excitability.
  • Acetaminophen/dextromethorphan/guaifenesin/phenylephrine should not be used in CHILDREN younger than 12 years old. Acetaminophen/dextromethorphan/guaifenesin/phenylephrine contains more than the recommended dose of acetaminophen for children this age and may cause liver damage.
  • Different brands of acetaminophen/dextromethorphan/guaifenesin/phenylephrine may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using acetaminophen/dextromethorphan/guaifenesin/phenylephrine while you are pregnant. It is not known if acetaminophen/dextromethorphan/guaifenesin/phenylephrine is found in breast milk. Do not breast-feed while taking acetaminophen/dextromethorphan/guaifenesin/phenylephrine.

Possible side effects of acetaminophen/ dextromethorphan/ guaifenesin/ 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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; nervousness; trouble sleeping; upset stomach.

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; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; redness; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent nervousness or trouble sleeping; shortness of breath; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; trouble urinating or inability to urinate; 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 blurred vision; confusion; dark urine; hallucinations; nausea, vomiting, or stomach pain; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat.

Proper storage of acetaminophen/dextromethorphan/guaifenesin/phenylephrine:

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

General information:

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

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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