IBSRELA Tablet Ref.[10240] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

IBSRELA is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

2. Dosage and Administration

The recommended dosage of IBSRELA in adults is 50 mg orally twice daily.

Administration Instructions:

  • Take IBSRELA immediately prior to breakfast or the first meal of the day and immediately prior to dinner [see Clinical Pharmacology (12.2)].
  • If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time.

10. Overdosage

Based on nonclinical data, overdose of IBSRELA may result in gastrointestinal adverse effects such as diarrhea as a result of exaggerated pharmacology with a risk for dehydration if diarrhea is severe or prolonged [see Warnings and Precautions (5.1)].

16.2. Storage and Handling

Store at room temperature, between 68°F and 77°F (20°C and 25°C).

Keep in original container and protect from moisture. Keep the container of IBSRELA tightly closed and in a dry place.

Do not remove desiccant from the bottle. Do not subdivide or repackage.

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