Home FDA labels b9e48f11-a6f6-4de4-e053-2a95a90a81ee FDA label b9e48f11-a6f6-4de4-e053-2a95a90a81ee 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 db001d27-1e22-4ef2-8dfd-2599a3e62a6e
SPL ID b9e48f11-a6f6-4de4-e053-2a95a90a81ee
Version 7
Effective date 2021-01-27
Source export date 2026-10-12
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:48:43 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 and cautions Warnings KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for use by children under 18 months of age. Store at room temperature. Do not expose to excessive heat over 40°C or 104°F. Do not use if seal is broken.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.