ARXO-2026-0329 · Reported
trace elements injection (zinc): Table 2 and Table 2 give different instructions for one patient
Table 2 reads “3 kg to 5 kg”. Table 2 reads “5 to 10 kg”. Example: An infant weighing exactly 5 kg matches both zinc rows: 250 and 100 mcg/kg/day. The text is in this label.
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
- trace elements injection (zinc) prescribing information (SPL set ID 995f1efa-aca0-4b6c-9099-f8e757c2133a)
- Place
- Table 2 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.
3 kg to 5 kg5 to 10 kg
How to check it without Arxo's tools
- Open Prescribing information, American Regent, Inc., SPL set ID 995f1efa-aca0-4b6c-9099-f8e757c2133a, version 4 (DailyMed) and find Table 2. Compare the text with the quotation above. A copy is kept in this register: 10cf5210c03c5624-995f1efa-aca0-4b6c-9099-f8e757c2133a-v4.xml (SHA-256
10cf5210c03c5624998dc96763c1dc23a9caf96e27acc96f280ec08ff730a74b, 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
- American Regent, 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 | American Regent, 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 American Regent, 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-2026-0329, https://arxo.io/findings/ARXO-2026-0329/ (status as of 2026-10-31). Data: ARXO-2026-0329.json.