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IMPORTANT SAFETY INFORMATION
Regulora® is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with irritable bowel syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments.
Regulora is a prescription mobile application for the treatment of adult abdominal pain due to IBS. US federal law restricts this mobile application device to sale by or on the order of a physician. Regulora is intended for patients who speak and read English. Regulora may not be appropriate for patients with mental or physical impairment that would prevent interacting with a mobile video application. Regulora may not be appropriate for patients with evidence of intestinal illness that better explains IBS symptoms such as celiac disease or inflammatory bowel disease. Regulora should not be used in lieu of your patient’s current IBS medication or therapy. In a clinical trial of Regulora, side effects were low. About 1% of patients experienced abdominal pain, constipation, fatigue, or headache which was thought to be related to using Regulora.