Home FDA labels 8158963c-7e9a-4d61-8ee4-0bf99d496486 FDA label 8158963c-7e9a-4d61-8ee4-0bf99d496486 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 849fa5d5-fc5e-4225-a4fc-e8346ef89369
SPL ID 8158963c-7e9a-4d61-8ee4-0bf99d496486
Version 8
Effective date 2019-05-08
Source export date 2026-11-06
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/2026-11-06/7dfa569f2d8f065241260fd9a4886d0ef0a3120fd6ee31d6d07c234e689e8c91/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run 20261106T075659Z
Imported at 2026-11-06 08:17:39 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.
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 REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see Overdosage Section).
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.