Home FDA labels 44225c82-50f0-26f6-e063-6394a90a53ac FDA label 44225c82-50f0-26f6-e063-6394a90a53ac 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 f8346bd2-72af-e396-e053-6294a90ab602
SPL ID 44225c82-50f0-26f6-e063-6394a90a53ac
Version 4
Effective date 2025-11-21
Source export date 2026-11-06
Source partition 12
Source file https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-11-06/8ec9b1418c25a8bb472a36e6bc0b2cbabb210d48d5dd734197e022d21529ed58/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run 20261106T075659Z
Imported at 2026-11-06 09:18:36 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 For external use only Allergy alert: This product may cause a severe allergic reaction.Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.