Poly-Vent IR

There are many brands and forms of guaifenesin and pseudoephedrine available and not all brands are listed on this leaflet.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

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

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

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.

You should not use guaifenesin and pseudoephedrine if you are allergic to it.

Do not use guaifenesin and pseudoephedrine 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 this medication if you have:

• high blood pressure, heart disease, coronary artery disease;

• diabetes;

• circulation problems;

• glaucoma;

• overactive thyroid; or

• enlarged prostate or problems with urination.

It is not known if this medication may be harmful to an unborn baby. Do not use this medicine without medical advice if you are pregnant.

Guaifenesin and pseudoephedrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without medical advice if you are breast-feeding a baby.

Artificially sweetened liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

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

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug.

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

Stop using guaifenesin and pseudoephedrine and call your doctor at once if you have:

• fast, pounding, or uneven heartbeat; or

• severe anxiety or nervousness.

Common side effects may include:

• dry mouth, nose, or throat;

• upset stomach, loss of appetite, vomiting;

• feeling excited or restless (especially in children);

• sleep problems (insomnia); or

• headache, dizziness.

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.