pantoprazole sodium for injection: 2.1 and 12.3 give different instructions for one patient

2.1 reads “Greater than 15 kg up to 40 kg”. 12.3 reads “body weight of 40 kg and greater”. Example: A child weighing exactly 40 kg gets 20 mg by 2.1 and 40 mg by 12.3. The same text is in 5 labels from 3 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

pantoprazole sodium for injection prescribing information (SPL set ID 51e4144a-489e-436c-609a-39305f8f56ba)

Place

2.1 and 12.3

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.

Greater than 15 kg up to 40 kg

body weight of 40 kg and greater

How to check it without Arxo's tools

1. Open Prescribing information, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., SPL set ID 51e4144a-489e-436c-609a-39305f8f56ba, version 60 (DailyMed) and find 2.1; 12.3. Compare the text with the quotation above. A copy is kept in this register: 310324b8628d46a8-51e4144a-489e-436c-609a-39305f8f56ba-v60.xml (SHA-256 310324b8628d46a8de8760b13eedf2793a0cf1b092183df17070aae7dfb76a26, 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

• Pfizer — 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 Pfizer (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-2026-0318, https://arxo.io/findings/ARXO-2026-0318/ (status as of 2026-10-31). Data: ARXO-2026-0318.json.