ARXO-2026-0305 · Reported
amoxicillin: 2.2 and 8.4 give different instructions for one patient
2.2 reads “Aged 3 Months (12 weeks) and Older”. 8.4 reads “12 weeks or younger (3 months or younger)”. Example: An infant aged exactly 12 weeks falls under Table 1 of 2.2 and also under the 30 mg/kg/day upper limit of 8.4 and Highlights. The same text is in 181 labels from 35 labelers in the DailyMed release of 29 October 2026.
Consequence
Potential effect on a prescribing decision: low; careful reading of the whole label usually resolves it. Arxo does not say which instruction is correct and gives no dose.
- Jurisdiction
- United States — federal
- Act
- amoxicillin prescribing information (SPL set ID 06e5c07d-d95c-4955-8d35-a4703ca2359e)
- Place
- 2.2 and 8.4
- 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.
Aged 3 Months (12 weeks) and Older12 weeks or younger (3 months or younger)
How to check it without Arxo's tools
- Open Prescribing information, USAntibiotics, LLC, SPL set ID 06e5c07d-d95c-4955-8d35-a4703ca2359e, version 5 (DailyMed) and find 2.2; 8.4. Compare the text with the quotation above. A copy is kept in this register: d9090eee66acd399-06e5c07d-d95c-4955-8d35-a4703ca2359e-v5.xml (SHA-256
d9090eee66acd399c5013fa6c3d26a7d9e8f8b633828db6da37970822264f2b3, 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
- USAntibiotics, LLC — 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 | USAntibiotics, LLC | ||
| 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 USAntibiotics, LLC (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-2026-0305, https://arxo.io/findings/ARXO-2026-0305/ (status as of 2026-10-31). Data: ARXO-2026-0305.json.