When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to balsalazide, aminosalicylates, or salicylates (such as aspirin).

How to Use This Medicine:
Capsule, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is not for long-term use.
• It is best to take this medicine with food or milk.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or pyloric stenosis. Tell your doctor if you are on a low-sodium diet.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful urination
• Increased bloody or black diarrhea, cramps, headache, stomach pain
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Mild diarrhea, nausea, or vomiting
• Runny or stuffy nose, sneezing, or cough
• Tiredness or unusual bruising

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088