Home FDA labels 1f1dbf7b-b3f1-4806-e063-6394a90abca8 FDA label 1f1dbf7b-b3f1-4806-e063-6394a90abca8 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 f40ea909-9df7-c90a-e053-2995a90a2987
SPL ID 1f1dbf7b-b3f1-4806-e063-6394a90abca8
Version 2
Effective date 2024-08-07
Source export date 2026-10-30
Source partition 6
Source file https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-30/e37bebe0ee356110e46fe9b102632217cd5fd64caa93a64cf6ef0d92a0bfdb4c/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run 20261102T182004Z
Imported at 2026-11-02 18:50:15 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). To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.