ARXO-2026-0301 · Reported
meloxicam tablets: Highlights, Dosage and Administration and 2.4 give different instructions for one patient
Highlights, Dosage and Administration reads “7.5 mg/kg once daily in children ≥60 kg”. 2.4 reads “7.5 mg once daily in children who weigh ≥60 kg”. Example: For a child of 60 kg, Highlights read literally gives 7.5 mg per kg (450 mg a day); section 2.4 gives 7.5 mg. The same text is in 4 labels from 2 labelers in the DailyMed release of 29 October 2026.
Consequence
Potential effect on a prescribing decision: high. Arxo does not say which instruction is correct and gives no dose.
- Jurisdiction
- United States — federal
- Act
- meloxicam tablets prescribing information (SPL set ID 445dc4f6-daac-e2f1-e063-6394a90a0ca5)
- Place
- Highlights, Dosage and Administration and 2.4
- 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.
7.5 mg/kg once daily in children ≥60 kg7.5 mg once daily in children who weigh ≥60 kg
How to check it without Arxo's tools
- Open Prescribing information, Advanced Rx of Tennessee, LLC, SPL set ID 445dc4f6-daac-e2f1-e063-6394a90a0ca5, version 2 (DailyMed) and find Highlights, Dosage and Administration; 2.4. Compare the text with the quotation above. A copy is kept in this register: 35a80b1e1d0675dc-445dc4f6-daac-e2f1-e063-6394a90a0ca5-v2.xml (SHA-256
35a80b1e1d0675dc815b1b768a7e45bd21f6ab88a32854c6ff972cf08be37af7, 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
- Advanced Rx of Tennessee, LLC — holder of the labeling
- Bryant Ranch Prepack — 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 | Advanced Rx of Tennessee, LLC | ||
| 2026-10-31 | Bryant Ranch Prepack | ||
| 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 Advanced Rx of Tennessee, LLC (e-mail)
- 2026-10-31Reported to Bryant Ranch Prepack (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-2026-0301, https://arxo.io/findings/ARXO-2026-0301/ (status as of 2026-10-31). Data: ARXO-2026-0301.json.