Home FDA labels 78f4cd01-d1c0-4993-911b-273749eeda55 FDA label 78f4cd01-d1c0-4993-911b-273749eeda55 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 cb28b79d-d807-4580-b82a-5a374ea37614
SPL ID 78f4cd01-d1c0-4993-911b-273749eeda55
Version 1
Effective date 2015-06-09
Source export date 2026-10-12
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 03:03:31 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.
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: Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. If pregnant or breast feeding, ask a doctor before using product.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.