When This Medicine Should Not Be Used:
Do not use this medicine if you have had an allergic reaction to glycerol phenylbutyrate. Do not give this medicine to a child younger than 2 months old.

How to Use This Medicine:
Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• This medicine may be given through a feeding tube (nasogastric tube or gastrostomy tube).
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  • Use an oral syringe to measure the dose. Place it on the tip of the feeding tube.
  • Inject the medicine into the tube.
  • Flush the tube with 30 mL of water to rinse all of the medicine into the stomach.
  • Rinse the tube again with another 30 mL of water to clear the tube.
• Carefully follow your doctor's instructions about any special diet.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

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 also using haloperidol (Haldol®), probenecid (Benemid®), valproic acid (Depakene®), or a steroid (such as dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, Medrol®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, nerve problems, or digestive problems, including problems with your pancreas.
• Make sure your doctor knows if you have used a phenylbutyrate medicine before.
• 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
• Burning, tingling, numbness or pain in the hands, arms, feet, or legs
• Confusion, memory problems
• Lightheadedness, headache, trouble hearing
• Nausea or vomiting, seizures, yellow eyes or skin
• Unusual sleepiness, tiredness, or weakness

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

• Decreased appetite
• Diarrhea, gas, nausea, vomiting, stomach pain
• Rash

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