Home FDA labels 4ee6bc22-bf74-ee36-e063-6394a90a268b Sodium Citrate and Citric Acid 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)
Brand name Sodium Citrate and Citric Acid
Generic name SODIUM CITRATE AND CITRIC ACID
Manufacturer Chartwell Governmental & Specialty RX, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 58c24504-47de-487a-ab8d-18add155ea95
SPL ID 4ee6bc22-bf74-ee36-e063-6394a90a268b
Version 2
Effective date 2026-04-07
Source export date 2026-09-28
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/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:37:54 Harmonized routes table Harmonized routes ORAL
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 · 18 matching rows.
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Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS Sodium citrate and citric acid oral solution is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.