Renacidin

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
Renacidin
Generic name
CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE
Manufacturer
United-Guardian, Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
13a9bbba-db21-4cba-991c-5d8afaf2ed74
SPL ID
73bb8d15-8d5c-426c-b42f-504a5da9cb8e
Version
3
Effective date
2019-12-17
Source export date
2026-09-28
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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:43:46
Harmonized routes table
Harmonized routes
IRRIGATION

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Renacidin use should be stopped immediately if the patient develops fever, urinary tract infection, signs and symptoms consistent with urinary tract infection, or persistent flank pain. Irrigation should be stopped if elevated serum creatinine develops. The contents of individual Renacidin containers should not be combined for use as continuous irrigation of the urinary tract because of complications that may arise from inadequate aseptic technique. Terminal sterilization processes that are not adequate may result in sepsis and/or injury to product handlers (e.g., irritation to exposed, unprotected areas of the skin). Serious adverse reactions, including sepsis and hypermagnesemia, have been reported to occur when Renacidin was used for continuous irrigation of the upper urinary tract. Renacidin is not indicated for continuous irrigation of the upper urinary tract.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The most common adverse reactions with use of Renacidin for dissolution of bladder calculi or prevention of encrustations of indwelling urethral catheters are “bladder irritability” and chemical cystitis, both reported to occur in approximately 3% of patients. A transient burning sensation in the bladder following Renacidin has been reported to occur in less than 1% of patients receiving Renacidin.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.