Home FDA labels e5cef58f-a6f6-4cb0-ab4b-2c4346acedf1 FDA label e5cef58f-a6f6-4cb0-ab4b-2c4346acedf1 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 4b4ff50f-d2f9-4c64-9c45-e470de13210a
SPL ID e5cef58f-a6f6-4cb0-ab4b-2c4346acedf1
Version 104
Effective date 2024-09-30
Source export date 2026-10-30
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
Source manifest SHA-256 b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run 20261102T182004Z
Imported at 2026-11-02 18:57:21 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.