remifentanil: 2.7 and Table 2 give different instructions for one patient

2.7 reads “birth to 12 years of age”. Table 2 reads “1 to 12 years”. Table 2 reads “birth to 2 months of age”. Example: A child aged 7 months has no row in Table 2, while 2.7 sends the reader to Table 2 for all children from birth to 12 years. The same text is in 6 labels from 4 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

remifentanil prescribing information (SPL set ID 8b4c8696-e23e-4c51-a4d2-babab5bd945a)

Place

2.7 and Table 2

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.

birth to 12 years of age

1 to 12 years

birth to 2 months of age

How to check it without Arxo's tools

1. Open Prescribing information, Mylan Institutional LLC, SPL set ID 8b4c8696-e23e-4c51-a4d2-babab5bd945a, version 6 (DailyMed) and find 2.7; Table 2. Compare the text with the quotation above. A copy is kept in this register: 489c9f6ff3e80542-8b4c8696-e23e-4c51-a4d2-babab5bd945a-v6.xml (SHA-256 489c9f6ff3e80542ee103417b25b55f11d71b2eafb8027aa8c6475823d01d5b8, copy of the official file).
2. 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

• Viatris — holder of the labeling
• U.S. Food and Drug Administration, Center for Drug Evaluation and Research — regulator of prescription drug labeling

Reported to

Responses

No response recorded.

History

1. 2026-10-31Confirmed by Arxo
2. 2026-10-31Reported to Viatris (e-mail)
3. 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-2026-0309, https://arxo.io/findings/ARXO-2026-0309/ (status as of 2026-10-31). Data: ARXO-2026-0309.json.