There are many brands and forms of guaifenesin and phenylephrine 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.

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

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

Gilphex TR 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.

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 or 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 cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

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.

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

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

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.

Store at room temperature away from moisture and heat.

You should not use Gilphex TR if you are allergic to it.

Do not use Gilphex TR 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 Gilphex TR without medical advice if you are pregnant.

Guaifenesin and phenylephrine 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).

Since Gilphex TR is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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 can increase certain side effects of guaifenesin and phenylephrine.

Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Gilphex TR 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.

Gilphex TR may cause serious side effects. Stop using Gilphex TR and call your doctor at once if you have:

• fast, pounding, or uneven heartbeat; or

• severe anxiety or nervousness.

Common side effects of Gilphex TR 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.

Ask a doctor or pharmacist before using Gilphex TR if you are also using 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 listed in this medication guide.

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