Home FDA labels a63d3ace-768f-4e1b-a5e9-dad1817453b9 FDA label a63d3ace-768f-4e1b-a5e9-dad1817453b9 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 a63d3ace-768f-4e1b-a5e9-dad1817453b9
SPL ID a63d3ace-768f-4e1b-a5e9-dad1817453b9
Version 1
Effective date 2011-07-07
Source export date 2026-11-06
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-11-06/2d7d9682bb1dc608c198b25f4655629e874bd36827b741e40512d5288afcc775/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run 20261106T075659Z
Imported at 2026-11-06 09:21:08 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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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.