Home FDA labels fc9b8ece-723a-400a-a6dc-2fa45e818d5b FDA label fc9b8ece-723a-400a-a6dc-2fa45e818d5b 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 5b9ee1bb-1deb-4cac-840e-30e20867a5f9
SPL ID fc9b8ece-723a-400a-a6dc-2fa45e818d5b
Version 4
Effective date 2021-05-08
Source export date 2026-08-01
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-01/f23e8214fa581dc87bce024b3f15739356a8bb6f9298e3d6be38c21c662a4211/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run 20260801T225920Z
Imported at 2026-08-01 23:06:07 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily. To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.