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guaifenesin, hydrocodone, and pseudoephedrine

Pronunciation: gwye FEN e sin, HYE droe KOE done, SOO doe ee FED rin

Brand: Entex HC, Hycofenix, Su-Tuss HD Elixir

What is the most important information I should know about guaifenesin, hydrocodone, and pseudoephedrine?

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

What is guaifenesin, hydrocodone, and pseudoephedrine?

Guaifenesin, hydrocodone, and pseudoephedrine is a combination medicine used to treat cough, stuffy nose, sinus congestion, and chest congestion caused by the common cold.

This medicine will not treat a cough with mucus, or cough that is caused by smoking, emphysema, or chronic bronchitis.

Guaifenesin, hydrocodone, and pseudoephedrine contains a narcotic cough medicine and may be habit-forming.

Guaifenesin, hydrocodone, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking guaifenesin, hydrocodone, and pseudoephedrine?

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use this medicine if you are allergic to guaifenesin, hydrocodone, or pseudoephedrine, or if you have:

  • narrow-angle glaucoma;
  • severe or uncontrolled high blood pressure;
  • coronary artery disease (clogged arteries); or
  • if you are unable to urinate.

This medicine is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

  • asthma or other breathing problems;
  • a head injury or increased pressure inside your skull;
  • diabetes;
  • thyroid disorder;
  • Addison's disease (an adrenal gland disorder);
  • liver or kidney disease;
  • an enlarged prostate or urination problems; or
  • stomach problems.

If you use hydrocodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Do not breast-feed. Hydrocodone can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.

How should I take guaifenesin, hydrocodone, and pseudoephedrine?

Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Take this medicine only until your symptoms clear up.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Read and carefully follow the instructions provided with this medicine about how to safely dispose of any unused portion.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include extreme drowsiness, feeling weak or limp, cold and clammy skin, breathing problems, fast or slow heartbeats, confusion, hallucinations, slurred speech, blue lips, slow breathing, fainting, or breathing that stops.

What should I avoid while taking guaifenesin, hydrocodone, and pseudoephedrine?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.

What are the possible side effects of guaifenesin, hydrocodone, and pseudoephedrine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Stop using this medicine and call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing;
  • confusion, severe weakness or drowsiness;
  • tremors, severe restlessness;
  • a seizure;
  • irregular heartbeats;
  • severe headache, blurred vision, pounding in your neck or ears;
  • a light-headed feeling, like you might pass out;
  • severe constipation, stomach pain; or
  • adrenal gland problems --nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

  • dizziness, drowsiness;
  • headache;
  • sleep problems (insomnia);
  • nausea; or
  • low blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect guaifenesin, hydrocodone, and pseudoephedrine?

Using this medicine with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
  • medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
  • other narcotic medications --opioid pain medicine or prescription cough medicine;
  • a sedative like Valium --diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others; or
  • drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness.

This list is not complete. Other drugs may affect guaifenesin, hydrocodone, and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about guaifenesin, hydrocodone, and pseudoephedrine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2019 Cerner Multum, Inc. Version: 6.01. Revision date: 12/13/2018.

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