Home FDA labels 9b276996-8d3e-4930-b146-ce3fe0afe4f9 FDA label 9b276996-8d3e-4930-b146-ce3fe0afe4f9 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 d313367c-8b17-4e18-9d27-e57033a75fe0
SPL ID 9b276996-8d3e-4930-b146-ce3fe0afe4f9
Version 2
Effective date 2019-09-05
Source export date 2026-10-12
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:41:28 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: Consult a physician for use in children under 12 years of age. If pregnant or breast-feeding, ask a health professional before use. If symptoms persist or worsen, discontinue use and contact a health care professional. KEEP OUT OF THE REACH OF CHILDREN.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.