Plecanatide U.S. label context · version 1
This page preserves this version's wording and source pins. Open the current profile →
What does the U.S. product label say?
Trulance · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The cited label covers chronic idiopathic constipation and IBS with constipation in adults. Pediatric effectiveness and safety have not been established. Label: 1, 8.4 ↗
Which safety limits matter?
The boxed warning concerns serious dehydration in pediatric patients. The product is contraindicated below age six and the label advises avoiding use at ages six through seventeen. Known or suspected mechanical gastrointestinal obstruction is also contraindicated; severe diarrhea can occur. Label: 1, 4, 5, 8.4, boxed warning ↗
Label edition and source pins
U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
TRULANCE (plecanatide) tablet · SPL version 15 · published 2024-04-05
Label ZIP SHA-256: 0d42da0dc89f9dad302f67bcff3df820d6dffe4743c9999083d93df18c88c534. Extracted XML SHA-256: 3ff2626593747b7b8c7e3c379036fec8f8a4f83a19229be9997b73801ed43470.