Potassium 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
- Brand name
- Potassium Citrate and Citric Acid
- Generic name
- POTASSIUM CITRATE AND CITRIC ACID
- Manufacturer
- Chartwell RX, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 978a5a9d-f0ca-4308-a84b-3b132263bbb8
- SPL ID
- 32598dec-73a0-13fd-e063-6294a90ad1ce
- Version
- 2
- Effective date
- 2025-04-09
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:26:29
| 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.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| brand name | Potassium Citrate and Citric Acid | openfda.brand_name | |
| generic name | POTASSIUM CITRATE AND CITRIC ACID | openfda.generic_name | |
| manufacturer name | Chartwell RX, LLC | openfda.manufacturer_name | |
| ndc | package | 62135-435-47 | openfda.package_ndc |
| ndc | package | 62135-435-05 | openfda.package_ndc |
| ndc | package | 62135-435-24 | openfda.package_ndc |
| ndc | product | 62135-435 | openfda.product_ndc |
| ndc11 | package | 62135043524 | derived:openfda.package_ndc |
| ndc11 | package | 62135043505 | derived:openfda.package_ndc |
| ndc11 | package | 62135043547 | derived:openfda.package_ndc |
| rxcui | 309318 | openfda.rxcui | |
| spl id | 32598dec-73a0-13fd-e063-6294a90ad1ce | id | |
| spl set id | 978a5a9d-f0ca-4308-a84b-3b132263bbb8 | set_id | |
| unii | 2968PHW8QP | openfda.unii | |
| unii | EE90ONI6FF | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Potassium 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 hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities, and other symptoms associated with a high concentration of potassium in the serum. Periodic determinations of serum electrolytes should be carried out in those patients with renal disease in order to avoid these complications. Hyperkalemia may exhibit the following electrocardiographic abnormalities: Disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves, etc.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.