Linaclotide 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?
Linzess · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The June 2026 label distinguishes IBS with constipation in adults and children aged seven years and older, chronic idiopathic constipation in adults, and functional constipation in children aged two years and older. Label: 1 ↗
Which safety limits matter?
The boxed warning concerns serious dehydration in children younger than two, for whom the product is contraindicated. The label also lists known or suspected mechanical gastrointestinal obstruction as a contraindication and describes potentially severe diarrhea. Label: 1, 4, 5, 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.
LINZESS (linaclotide) capsule · SPL version 39 · published 2026-06-01
Label ZIP SHA-256: 77c54fc2bf053002e1fd77970d745d4088919827b5a4a74d5d139cf8df320a54. Extracted XML SHA-256: 0e36407b126e3d4b3c616c030ed28362be4484ad305e337e12c319145523082a.