SudoGest is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian tubes.

SudoGest may also be used for purposes not listed in this medication guide.

Follow all directions on the label and package. Use exactly as directed.

Use exactly as directed on the label, or as prescribed by your doctor.

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.

Take with a full glass of water.

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

You may need to shake the oral suspension (liquid) well just before you measure a dose. 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.

Call your doctor if your symptoms do not improve after 7 days of treatment or if you have a fever.

Store at room temperature away from moisture and heat.

You should not use SudoGest if you are allergic to SudoGest.

Do not use SudoGest 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.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• heart disease or high blood pressure;

• enlarged prostate and urination problems;

• diabetes; or

• a thyroid disorder.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Since SudoGest is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cough or cold medicine. Many combination medicines contain SudoGest or another decongestant. Taking certain products together can cause you to get too much of this type of medicine.

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

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

• dizziness;

• nervousness; or

• sleep problems (insomnia).

Less serious side effects may be more likely, and you may have none at all.

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.

Other drugs may affect SudoGest, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.