Thiola is used together with diet, fluids, and other medicines to help prevent kidney stones in adults and children weighing at least 44 pounds (20 kilograms).

Thiola is usually given after diet, increased fluid intake, or other medications have failed.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Drink plenty of liquids while you are taking Thiola.

You will need frequent urine tests.

Store at room temperature away from moisture and heat.

You should not use Thiola if you are allergic to it.

Thiola should not be given to a child who is unable to swallow a tablet.

Tell your doctor if you are pregnant. It is not known whether Thiola will harm an unborn baby. However, having a kidney stone during pregnancy may cause complications such as low birth weight or premature birth. The benefit of preventing kidney stones may outweigh any risks to the baby.

You should not breastfeed while using Thiola.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Avoid drinking alcohol 2 hours before and 3 hours after taking Thiola.

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

Call your doctor at once if you have signs of kidney problems--puffy eyes, swelling in your ankles or feet, weight gain, or urine that looks foamy.

Common side effects of Thiola may include:

• nausea, diarrhea, vomiting;

• feeling tired;

• fever;

• muscle or joint pain;

• foamy urine;

• rash; or

• mouth sores.

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.