First Mounjaro label revision adds carton, Medication Guide and package insert changes

The Food and Drug Administration approved two labeling supplements for Mounjaro (tirzepatide) on July 28, 2023, marking the first update to the drug's official prescribing information since it was originally approved in May 2022 ^[1]. The two actions, filed as SUPPL-2 and SUPPL-6 under New Drug Application 215866, were both classified as labeling changes and were approved together ^[1].

SUPPL-2 covered three separate labeling elements at once: the container and carton labels, the Medication Guide that patients receive with their prescription, and the package insert used by prescribers and pharmacists ^[1]. SUPPL-6 was narrower, covering only the package insert ^[1]. Eli Lilly and Company, the maker of Mounjaro, is listed as the sponsor on the FDA's Drugs@FDA database entry for NDA 215866 ^[1].

According to the FDA's public record, this July 2023 action was the earliest labeling supplement listed after the original approval, and it was followed by at least a dozen more labeling-related submissions through 2026, including additional package insert updates in November 2024, May 2025 and September 2025, along with a Medication Guide and carton labeling update in January 2026 ^[1]. The database also shows later supplements tied to new patient populations, a new indication and a new dosing regimen, filed as SUPPL-39, SUPPL-44 and SUPPL-45, respectively ^[1].

The sources reviewed do not spell out the specific content of the July 2023 changes—that is, exactly what new warnings, instructions or safety language were added to the carton, Medication Guide or insert. The FDA's Drugs@FDA listing confirms the approval date, the submission numbers and the categories of labeling affected, but the underlying label text and approval letter would need to be reviewed separately to know precisely what changed ^[1].

Why it matters for patients

Label and Medication Guide updates are how the FDA and drugmakers communicate new or revised safety information, dosing details, or usage instructions to patients and doctors after a drug is already on the market. When a Medication Guide changes, pharmacies are required to give patients the updated version with their prescription. When carton labeling changes, the physical packaging patients see at the pharmacy may look different, even though the medicine inside is the same.

Because Mounjaro's label has been revised more than a dozen times since this first July 2023 update, patients who have been on the drug for a while may find that the paperwork, warnings or instructions they receive today differ from what they got when they started treatment ^[1]. This is a normal part of how the FDA manages a drug over time as more data comes in, but it also means patients and caregivers may want to read updated Medication Guides even if they have used the drug before, since new information can appear without any change to the medicine itself.

What happens next

The FDA's public record shows a long history of subsequent labeling actions for Mounjaro, including package insert updates on November 1, 2024, May 28, 2025 and September 25, 2025, a new patient population supplement on December 19, 2025, and a Medication Guide, carton label and package insert update on January 20, 2026 ^[1]. Further supplements for a new indication and a new dosing regimen were listed with an August 27, 2026 action date ^[1]. The sources do not describe the substance of these later changes beyond their category labels, so the specific safety or usage information involved is not yet known from what is available here.