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
- Direct_Rx
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 946b9568-671d-172a-e053-2a95a90ac827
- SPL ID
- 2c4e994c-a009-5fc9-e063-6294a90a462a
- Version
- 6
- Effective date
- 2025-01-22
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:09:09
| 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 | 210733 | derived:openfda.application_number |
| application number | ANDA210733 | openfda.application_number | |
| brand name | POTASSIUM CHLORIDE | openfda.brand_name | |
| generic name | POTASSIUM CHLORIDE | openfda.generic_name | |
| manufacturer name | Direct_Rx | openfda.manufacturer_name | |
| ndc | package | 72189-027-30 | openfda.package_ndc |
| ndc | package | 72189-027-04 | openfda.package_ndc |
| ndc | product | 72189-027 | openfda.product_ndc |
| ndc11 | package | 72189002730 | derived:openfda.package_ndc |
| ndc11 | package | 72189002704 | derived:openfda.package_ndc |
| rxcui | 628953 | openfda.rxcui | |
| spl id | 2c4e994c-a009-5fc9-e063-6294a90a462a | id | |
| spl set id | 946b9568-671d-172a-e053-2a95a90ac827 | set_id | |
| unii | 660YQ98I10 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
5.1 Gastrointestinal Adverse Reactions Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly if the drug maintains contact with the gastrointestinal mucosa for prolonged periods. Consider the use of liquid potassium in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders. If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue K-TAB and consider possibility of ulceration, obstruction or perforation. K-TAB should not be taken on an empty stomach because of its potential for gastric irritation [see Dosage and Administration (2.1)].
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS SECTION The following adverse reactions have been identified with use of oral potassium salts. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. There have been reports hyperkalemia and of upper and lower gastrointestinal condition including obstruction, bleeding, ulceration, perforation. Skin rash has been reported rarely.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.