Home FDA labels b9255a50-c0ac-4039-afaf-fbe2c133d254 FDA label b9255a50-c0ac-4039-afaf-fbe2c133d254 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 267da0d1-b36b-425c-bb9d-7c778e1d65d0
SPL ID b9255a50-c0ac-4039-afaf-fbe2c133d254
Version 2
Effective date 2019-01-15
Source export date 2026-10-22
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-22/0bafccaf0213baa649cda9c1c2365d28432e10cf46f4167b2ea41290b5cac2b8/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run 20261023T001338Z
Imported at 2026-10-23 00:59:22
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 Warnings Allergy Alert This product may cause a severe allergic reaction. Symptoms may include: • hives • facial swelling • wheezing/difficulty breathing • shock • rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.