Potassium Chloride for Oral Solution

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: Potassium Chloride for Oral Solution
Generic name: POTASSIUM CHLORIDE
Manufacturer: Somerset Therapeutics, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 32809eae-1c3f-96fc-e063-6394a90aeaad
SPL ID: 32809cac-68f8-94d5-e063-6394a90a9395
Version: 1
Effective date: 2024-09-30
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:37:19

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	213467	derived:openfda.application_number
application number		ANDA213467	openfda.application_number
brand name		Potassium Chloride for Oral Solution	openfda.brand_name
generic name		POTASSIUM CHLORIDE	openfda.generic_name
manufacturer name		Somerset Therapeutics, LLC	openfda.manufacturer_name
ndc	package	70069-823-01	openfda.package_ndc
ndc	package	70069-823-30	openfda.package_ndc
ndc	package	70069-823-10	openfda.package_ndc
ndc	product	70069-823	openfda.product_ndc
ndc11	package	70069082301	derived:openfda.package_ndc
ndc11	package	70069082310	derived:openfda.package_ndc
ndc11	package	70069082330	derived:openfda.package_ndc
rxcui		1867544	openfda.rxcui
spl id		32809cac-68f8-94d5-e063-6394a90a9395	id
spl set id		32809eae-1c3f-96fc-e063-6394a90aeaad	set_id
unii		660YQ98I10	openfda.unii

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Gastrointestinal Irritation: Dilute before use, take with meals ( 5.1 ) 5.1 Gastrointestinal Irritation May cause gastrointestinal irritation.Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [see Dosage and Administration (2.1) ] .

Adverse reactions cross-check#

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

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. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 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.