Home FDA labels e8d6e3b9-e070-c62c-e053-2a95a90adb09 FDA label e8d6e3b9-e070-c62c-e053-2a95a90adb09 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 1e686d20-cae2-4d4b-9f6d-d01307aceab5
SPL ID e8d6e3b9-e070-c62c-e053-2a95a90adb09
Version 6
Effective date 2022-09-16
Source export date 2026-09-28
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:49:44 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 6 ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.