Home FDA labels 38f4e62a-91f3-a0a4-e063-6394a90a1be5 FDA label 38f4e62a-91f3-a0a4-e063-6394a90a1be5 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 11c1130f-ed64-a303-e063-6394a90ab283
SPL ID 38f4e62a-91f3-a0a4-e063-6394a90a1be5
Version 2
Effective date 2025-07-02
Source export date 2026-09-28
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:19:02 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 Citrate solution is generally well tolerated when given in recommended doses when the patient has normal renal functions. To report suspected adverse reactions, contact Brandywine Pharmaceuticals, LLC at 610-314-7943 or the 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.