Home FDA labels 5fae9b56-253b-b583-e053-2991aa0a8d59 FDA label 5fae9b56-253b-b583-e053-2991aa0a8d59 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 5ff1d8ae-8a4f-4a9b-9d92-8c3980866f55
SPL ID 5fae9b56-253b-b583-e053-2991aa0a8d59
Version 3
Effective date 2017-12-06
Source export date 2026-09-28
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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:21:22 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 AND PRECAUTIONS Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only. Warning: Rocuronium Bromide Injection may cause respiratory depression. Facilities for artificial respiration must be immediately available.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions • ADVERSE EVENTS To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.