ARXO-2026-0321 · Reported
PEG 3350 and electrolytes for oral solution: 7.2 and 2.1 give different instructions for one patient
7.2 reads “Administer oral medications within one hour before the start of administration of GoLYTELY”. 2.1 reads “Do not take oral medications within 1 hour before the start or during administration”. Example: A tablet taken 30 minutes before the opening dose follows 7.2 and breaks 2.1, Highlights and 17. The same text is in 9 labels from 8 labelers in the DailyMed release of 29 October 2026.
Consequence
Potential effect on a prescribing decision: medium. Arxo does not say which instruction is correct and gives no dose.
- Jurisdiction
- United States — federal
- Act
- PEG 3350 and electrolytes for oral solution prescribing information (SPL set ID 7609ecf7-0ce0-4fbb-9c27-30987f689575)
- Place
- 7.2 and 2.1
- Record
- Discrepancy
- Class
- Text of the act
- Where it arose
- The text of the act
- Arxo's conclusion
- Confirmed
- Official text
- Unchanged at last check
- Last checked
- 2026-10-31
Evidence
Reproduced by execution. Quotations are verbatim from the official material; translations are ours and marked.
Administer oral medications within one hour before the start of administration of GoLYTELYDo not take oral medications within 1 hour before the start or during administration
How to check it without Arxo's tools
- Open Prescribing information, Azurity Pharmaceuticals, Inc., SPL set ID 7609ecf7-0ce0-4fbb-9c27-30987f689575, version 1 (DailyMed) and find 7.2; 2.1. Compare the text with the quotation above. A copy is kept in this register: 159a2be285e0c194-7609ecf7-0ce0-4fbb-9c27-30987f689575-v1.xml (SHA-256
159a2be285e0c1940159e36bbcb624cb1e0d66ecbbe0f85e537b56fa6de29dcc, copy of the official file). - The finding holds if the quoted passages read as shown and the comparison gives the result stated at the top of this page. If it does not, write to us with the record ID.
How this finding was made
AI agents read the labels, compared their parts and, where marked, ran the example patient through executable rules; an AI agent then read each place in full, with tables and footnotes, and confirmed it. No clinician has assessed these places. A person at Arxo approved publication (2026-10-31).
Responsible institutions
- Azurity Pharmaceuticals, Inc. — holder of the labeling
- U.S. Food and Drug Administration, Center for Drug Evaluation and Research — regulator of prescription drug labeling
Reported to
| Date | Institution | Channel | Reference |
|---|---|---|---|
| 2026-10-31 | Azurity Pharmaceuticals, Inc. | ||
| 2026-10-31 | U.S. Food and Drug Administration, Center for Drug Evaluation and Research |
Responses
No response recorded.
History
- 2026-10-31Confirmed by Arxo
- 2026-10-31Reported to Azurity Pharmaceuticals, Inc. (e-mail)
- 2026-10-31Reported to U.S. Food and Drug Administration, Center for Drug Evaluation and Research (e-mail)
Cite this record
Arxo Law, Arxo Findings Register, ARXO-2026-0321, https://arxo.io/findings/ARXO-2026-0321/ (status as of 2026-10-31). Data: ARXO-2026-0321.json.