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 (canonical bytes are SHA-256 checked before publication)

Brand name: Potassium Chloride
Generic name: POTASSIUM CHLORIDE
Manufacturer: Lupin Pharmaceuticals,Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 1bbacdbb-91fa-4897-a00c-1b293de27b83
SPL ID: 21b5a86c-0f40-42f0-8e47-05062ce1f1f8
Version: 3
Effective date: 2020-04-27
Source export date: 2026-10-12
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/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:37:09

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	210241	derived:openfda.application_number
application number		ANDA210241	openfda.application_number
brand name		Potassium Chloride	openfda.brand_name
generic name		POTASSIUM CHLORIDE	openfda.generic_name
manufacturer name		Lupin Pharmaceuticals,Inc.	openfda.manufacturer_name
ndc	package	43386-194-31	openfda.package_ndc
ndc	package	43386-194-30	openfda.package_ndc
ndc	package	43386-194-90	openfda.package_ndc
ndc	product	43386-194	openfda.product_ndc
ndc11	package	43386019430	derived:openfda.package_ndc
ndc11	package	43386019431	derived:openfda.package_ndc
ndc11	package	43386019490	derived:openfda.package_ndc
rxcui		1867544	openfda.rxcui
spl id		21b5a86c-0f40-42f0-8e47-05062ce1f1f8	id
spl set id		1bbacdbb-91fa-4897-a00c-1b293de27b83	set_id
unii		660YQ98I10	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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. To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 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.