FDA.reportPublic FDA data

FDA label 968e1506-e58d-47c4-984b-e1be0b5b5781

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
7ef5655f-aeec-4c2a-beb7-9a328a9930d0
SPL ID
968e1506-e58d-47c4-984b-e1be0b5b5781
Version
2
Effective date
2014-08-21
Source export date
2026-08-01
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/0689a4374f1490600b5244071db3b04bd3bbc29ceda7a856edb8225323adf20a/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:00:18

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Warnings: If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if you have bloody or black stool. Stop use and ask a doctor if symptoms get worse or diarrhea lasts more than 2 days, have a fever, or have mucus in the stool. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea. Do not use if known sensitivity to Diarrhea or any of its ingredients exists.