warnings and cautions
5 WARNINGS AND PRECAUTIONS • Gastrointestinal Irritation: Dilute before use, take with meals (5.1) 5.1 Gastrointestinal Irritation 5.1 Gastrointestinal Irritation
Potassium Chloride
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 Chloride
- Generic name
- POTASSIUM CHLORIDE
- Manufacturer
- Guardian Drug Company
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 296eda62-ea8e-7a0c-e063-6294a90a9274
- SPL ID
- 5f75aa97-8df9-4594-a730-e4fd731498cd
- Version
- 3
- Effective date
- 2025-07-22
- 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 05:45:56
| 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 |
|---|---|---|---|
| application applno | ANDA | 219009 | derived:openfda.application_number |
| application number | ANDA219009 | openfda.application_number | |
| brand name | Potassium Chloride | openfda.brand_name | |
| generic name | POTASSIUM CHLORIDE | openfda.generic_name | |
| manufacturer name | Guardian Drug Company | openfda.manufacturer_name | |
| ndc | package | 53041-420-01 | openfda.package_ndc |
| ndc | package | 53041-420-49 | openfda.package_ndc |
| ndc | package | 53041-420-50 | openfda.package_ndc |
| ndc | product | 53041-420 | openfda.product_ndc |
| ndc11 | package | 53041042050 | derived:openfda.package_ndc |
| ndc11 | package | 53041042001 | derived:openfda.package_ndc |
| ndc11 | package | 53041042049 | derived:openfda.package_ndc |
| rxcui | 1867544 | openfda.rxcui | |
| spl id | 5f75aa97-8df9-4594-a730-e4fd731498cd | id | |
| spl set id | 296eda62-ea8e-7a0c-e063-6294a90a9274 | set_id | |
| unii | 660YQ98I10 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
6 ADVERSE REACTIONS The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Guardian Drug Company at 609-860-2600 or 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.