Home FDA labels a6439ee5-d23b-18af-e053-2995a90adc4a FDA label a6439ee5-d23b-18af-e053-2995a90adc4a 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 57fcfec0-23b8-570c-e053-2991aa0ab532
SPL ID a6439ee5-d23b-18af-e053-2995a90adc4a
Version 2
Effective date 2020-05-22
Source export date 2026-10-30
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-30/a900515c00f4d0d29f88cc94ee68daf127f036296f87a6b4a8a3f964cd0433c0/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run 20261102T182004Z
Imported at 2026-11-02 18:46:12 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 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.