Home FDA labels f780f27a-7ccc-7dd5-e053-6394a90a2163 FDA label f780f27a-7ccc-7dd5-e053-6394a90a2163 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 65346b3f-7a71-4b35-84c8-385ded952867
SPL ID f780f27a-7ccc-7dd5-e053-6394a90a2163
Version 4
Effective date 2023-03-22
Source export date 2026-10-30
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-30/eb45a4bb6908a5d117668eac8da5ce490c753c3f9b68298758ef131307d1d264/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run 20261102T182004Z
Imported at 2026-11-02 19:18:51 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.