Home FDA labels 19c45cf2-8b45-3d39-e063-6394a90a6e54 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 RX, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 525136c9-7758-437b-b57b-94b905786825
SPL ID 19c45cf2-8b45-3d39-e063-6394a90a6e54
Version 3
Effective date 2024-05-31
Source export date 2026-10-12
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/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:46:57 Harmonized routes table Harmonized routes ORAL
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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.