When This Medicine Should Not Be Used:
You should not use this medicine if you or your child have had an allergic reaction to sodium phenylbutyrate.

How to Use This Medicine:
Powder, Tablet, Coated Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• If you are using the oral powder, you can mix it with water or food (solid or liquid). Powder mixed with food should be used right away. Powder mixed in water can be stored for up to one week at room temperature or in the refrigerator.
• Carefully follow your doctor's instructions about any special diet.

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

• Make sure your doctor knows if you are using probenecid (Benemid®) or steroids (such as dexamethasone, prednisolone, prednisone, Celestone®, Cortone®, Decadron®, Deltasone®, or Pediapred®). Tell your doctor if you are also using haloperidol (Haldol®) or valproic acid (Depakene®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have heart disease, kidney disease, liver disease, or edema (swelling from excess fluid).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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
• Decrease in how much or how often you urinate.
• Heart rhythm problems.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Severe menstrual bleeding.
• Severe vomiting or rectal bleeding.
• Sudden or severe stomach pain, nausea, vomiting, fever, or lightheadedness.
• Swelling in your hand, ankles, or feet.
• Unusual bleeding, bruising, or weakness.

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

• Change in monthly periods.
• Depression.
• Headache or weight gain.
• Nausea or mild stomach pain.

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