Uristat Ultra is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).

Uristat Ultra is used to treat urinary symptoms such as pain or burning, increased urination, and increased urge to urinate. These symptoms can be caused by infection, injury, surgery, catheter, or other conditions that irritate the bladder.

Uristat Ultra will treat urinary symptoms, but this medication will not treat a urinary tract infection.. Take any antibiotic that your doctor prescribes to treat an infection.

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

You should not use Uristat Ultra if you have kidney disease.

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.

Take Uristat Ultra after meals.

Drink plenty of liquids while you are taking Uristat Ultra.

Uristat Ultra will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not harmful. Darkened urine may also cause stains to your underwear that may be permanent.

Uristat Ultra can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use Uristat Ultra for longer than 2 days unless your doctor has told you to.

This medication can cause unusual results with urine tests. Tell any doctor who treats you that you are using Uristat Ultra.

Store at room temperature away from moisture and heat.

You should not use Uristat Ultra if you are allergic to it, or if you have kidney disease.

To make sure Uristat Ultra is safe for you, tell your doctor if you have:

• liver disease;

• diabetes; or

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

FDA pregnancy category B. Uristat Ultra is not expected to harm an unborn baby. Do not use Uristat Ultra without a doctor's advice if you are pregnant.

It is not known whether phenazopyridine passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

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.

Do not use this medication while wearing soft contact lenses. Uristat Ultra can permanently discolor soft contact lenses.

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

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

• little or no urinating;

• swelling, rapid weight gain;

• confusion, loss of appetite, pain in your side or lower back;

• fever, pale or yellowed skin, stomach pain, nausea and vomiting; or

• blue or purple appearance of your skin.

Common side effects of Uristat Ultra may include:

• headache;

• dizziness; or

• upset stomach.

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 interact with phenazopyridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.