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.

guaifenesin, hydrocodone, and pseudoephedrine will not treat a cough with mucus, or a cough 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.

Follow the instructions on your prescription label and read all medication guides. Never use guaifenesin, hydrocodone, and pseudoephedrine in larger amounts or for longer than prescribed. Take this medicine only until your symptoms go away.

Never share opioid medicine with anyone else, 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 access it. Selling or giving away opioid medicine is illegal.

Measure liquid medicine carefully. Use the dosing syringe provided, or 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 along with a headache, cough, or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor beforehand if you have taken a cough or cold medicine in 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 on how to safely dispose of any unused portion.

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 happen if you use guaifenesin, hydrocodone, and pseudoephedrine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Do not use this medicine if you have taken an MAO inhibitor in the last 14 days. A serious drug interaction could happen. 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 cannot urinate.

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

Tell your doctor if you have ever had:

• asthma or other breathing issues;
• a head injury or higher pressure in your skull;
• diabetes;
• thyroid issues;
• Addison's disease (a condition affecting the adrenal glands);
• liver or kidney disease;
• an enlarged prostate or urination issues; or
• stomach problems.

If you take hydrocodone while pregnant, your baby may become dependent on the drug. This can lead to severe withdrawal symptoms in the baby after birth. Babies born dependent on addictive 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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.

This medicine may cause serious side effects. 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 of guaifenesin, hydrocodone, and pseudoephedrine 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.

Usual Adult Dose for Cough and Nasal Congestion:

10 mL orally every 4 to 6 hoursMaximum dose: 40 mL in 24 hours Comments:-Each 5 mL contains hydrocodone 2.5 mg; pseudoephedrine 30 mg; guaifenesin 200 mg -Measure dose with accurate measuring device. Use: Symptomatic relief of cough, nasal congestion, and to loosen mucus associated with the common cold.

Since this medicine is used as needed, you may not follow a dosing schedule. If you miss a dose and it's almost time for your next dose, just skip the missed dose. Do not take two doses at the same time.

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.

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

Avoid driving or operating machinery until you know how guaifenesin, hydrocodone, and pseudoephedrine 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.

Using this medicine with other drugs that slow your breathing can lead to serious side effects or even death. Talk to 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 serious side effects or death. Make sure your doctor knows if you are also using:

• 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, or 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.