Dextromethorphan, guaifenesin, and pseudoephedrine

Dextromethorphan is a medicine that helps stop coughing. It works on the brain signals that cause the cough reflex.

Guaifenesin is a medicine that helps clear congestion in your chest and throat, making it easier to cough it up.

Pseudoephedrine is a decongestant that reduces swelling in the blood vessels of the nasal passages. Swollen blood vessels can lead to a stuffy nose.

Dextromethorphan, guaifenesin, and pseudoephedrine is a combination medicine used to relieve cough, stuffy nose, sinus congestion, and chest congestion caused by allergies, the common cold, or the flu.

dextromethorphan, guaifenesin, and pseudoephedrine will not treat a cough caused by smoking, asthma, or emphysema.

Dextromethorphan, guaifenesin, and pseudoephedrine may also be used for reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken dextromethorphan, guaifenesin, and pseudoephedrine within the past few days.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

Do not use dextromethorphan, guaifenesin, and pseudoephedrine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

You should not use this medicine if you are allergic to dextromethorphan, guaifenesin, or pseudoephedrine.

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

Ask a doctor or pharmacist if it is safe for you to take dextromethorphan, guaifenesin, and pseudoephedrine if you have:

• high blood pressure or coronary artery disease;
• diabetes;
• glaucoma;
• epilepsy or other seizure disorder;
• enlarged prostate or urination problems;
• pheochromocytoma (an adrenal gland tumor); or
• cough with mucus, or cough caused by emphysema or chronic bronchitis.

It is not known whether dextromethorphan, guaifenesin, and pseudoephedrine will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

This medicine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Ask a doctor before using this medicine if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

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

This medication may cause serious side effects. Stop using this medication and call your doctor right away if you experience:

• fast or uneven heart rate;
• severe dizziness or anxiety, feeling like you might faint;
• severe headache;
• changes in mood;
• fever; or
• dangerously high blood pressure (which may include severe headache, blurred vision, ringing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Common side effects of dextromethorphan, guaifenesin, and pseudoephedrine may include:

• diarrhea;
• dizziness, drowsiness;
• sleep issues (insomnia); or
• feelings of nervousness, restlessness, or irritability.

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

Usual Adult Dose for Cough and Nasal Congestion:

Dose referred to by strength of dextromethorphan/guaiFENesin/pseudoephedrine (in mg) per unit of measurement:Oral liquids (liquid/drops/solution/syrup):10/187/30 per 5 mL: 10 mL every 4 hours, maximum 4 doses per day15/200/30 per 5 mL: 5 to 10 mL every 6 hours, maximum 40 mL per dayOral solids:20/380/60 per tablet: 1 tablet every 4 hours, maximum 4 doses per day 30/400/30 per tablet: 1 tablet every 6 hours, maximum 4 doses per day 30/400/60 per tablet: 1 tablet every 6 hours, maximum 4 doses per day

Usual Pediatric Dose for Cough and Nasal Congestion:

Dose referred to by strength of dextromethorphan/guaiFENesin/pseudoephedrine (in mg) per unit of measurement:Oral liquids (liquid/drops/solution/syrup):5/50/15 per 5 mL 6 to 12 years: 10 mL every 4 to 6 hours, maximum 4 doses per day 2 to under 6 years: 5 mL every 4 to 6 hours, maximum 4 doses per day 10/187/30 per 5 mL 2 to under 6 years: 2.5 mL every 4 hours, maximum 4 doses per day 6 to under 12 years: 5 mL every 4 hours, maximum 4 doses per day 12 years and older: 10 mL every 4 hours, maximum 4 doses per day15/200/30 per 5 mL 12+= 10 mL every 6 hours, maximum 4 doses per day 15/200/30 per 5 mL 12 years and older: 5 to 10 mL every 6 hours, maximum 40 mL per day6 to under 12 years: 2.5 to 5 mL every 6 hours, maximum 20 mL per day Oral solids:20/380/60 per tablet 12 years and older: 1 tablet every 4 hours, maximum 4 doses per day 6 to under 12 years: 1/2 tablet every 4 hours, maximum 4 doses per day 30/400/30 per tablet12 years and older: 1 tablet every 6 hours, maximum 4 doses per day 30/400/60 per tablet12 years and older: 1 tablet every 6 hours, maximum 4 doses per day 6 to under 12 years: 1/2 tablet every 6 hours, maximum 4 doses per day

Since this medicine is taken as needed, you might not have a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to make up for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

dextromethorphan, guaifenesin, and pseudoephedrine may cause blurred vision or affect your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of this medicine.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. dextromethorphan, guaifenesin, and pseudoephedrine are found in many combination medicines. Taking certain products together can lead to taking too much of a certain drug. Check the label to see if a medicine contains a decongestant, expectorant, or cough suppressant.

Ask a doctor or pharmacist before using this medicine if you are taking any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are mentioned in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can make these effects worse. Ask your doctor before taking this medicine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.