Home FDA labels a6077d16-83c2-41b4-9d6d-6c7e24bceec2 FDA label a6077d16-83c2-41b4-9d6d-6c7e24bceec2 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 40fe9d98-b546-4bd2-95f5-1dd563813daa
SPL ID a6077d16-83c2-41b4-9d6d-6c7e24bceec2
Version 3
Effective date 2016-12-08
Source export date 2026-10-12
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/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:35:35 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: Keep out of reach of children. In case of overdose, contact a physician or a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use. Tamper seal: "Sealed for your protection." Do not use if seal is broken or missing.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.