IMPORTANT RISK INFORMATION

• Do not give IBSRELA to children who are less than 6 years of age. It may harm them.
• You should not give IBSRELA to children 6 years to less than 18 years of age. It may harm them. IBSRELA can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
• Do not take IBSRELA if a doctor has told you that you have a bowel blockage (intestinal obstruction).

Before you take IBSRELA, tell your doctor about your medical conditions, including if you are:

• Pregnant or plan to become pregnant. It is not known if IBSRELA will harm your unborn baby.
• Breastfeeding or plan to breastfeed, although IBSRELA is not expected to pass into your breast milk and to harm your baby. Talk with your doctor about the best way to feed your baby if you take IBSRELA.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Side Effects

Diarrhea is the most common side effect of IBSRELA, and it can sometimes be severe. Stop taking IBSRELA and call your doctor if you develop severe diarrhea.

Other common side effects of IBSRELA include swelling, or a feeling of fullness or pressure in your abdomen (distension), gas (flatulence), or dizziness.

These are not all the possible side effects of IBSRELA. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch.