Home FDA labels 12905645-cda5-45b4-b125-5d25d5d677cc FDA label 12905645-cda5-45b4-b125-5d25d5d677cc 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 619a3a3f-039e-437f-b734-2f6dd280c029
SPL ID 12905645-cda5-45b4-b125-5d25d5d677cc
Version 4
Effective date 2016-12-01
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 WARNINGS: Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away. If pregnant or breast-feeding, seek advice of 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.