glycopyrrolate oral solution: Table 1, 18 to 22 kg, Dose Level 2 has no instruction for a patient the label covers

Table 1, 18 to 22 kg, Dose Level 2 reads “0.8 mL”. Example: The cell sits in the milligram column. Read as printed, 0.8 mL of a 1 mg/5 mL solution is 0.16 mg, while the volume column of the same row gives 4 mL. The same text is in 5 labels from 5 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

glycopyrrolate oral solution prescribing information (SPL set ID d200bd44-9856-4104-a29e-a4cca3db6737)

Place

Table 1, 18 to 22 kg, Dose Level 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

Contradiction within the text. Quotations are verbatim from the official material; translations are ours and marked.

0.8 mL

How to check it without Arxo's tools

1. Open Prescribing information, Merz Pharmaceuticals, LLC, SPL set ID d200bd44-9856-4104-a29e-a4cca3db6737, version 20 (DailyMed) and find Table 1, 18 to 22 kg, Dose Level 2. Compare the text with the quotation above. A copy is kept in this register: a5348a34bbc674f4-d200bd44-9856-4104-a29e-a4cca3db6737-v20.xml (SHA-256 a5348a34bbc674f4f74fcc76f2332434391d6a2266f2ab0ca02a7174789e9ecc, 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

• Merz Pharmaceuticals, LLC — 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 Merz Pharmaceuticals, LLC (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-2026-0312, https://arxo.io/findings/ARXO-2026-0312/ (status as of 2026-10-31). Data: ARXO-2026-0312.json.