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: 28c49165-d8c9-443a-b000-953b8e1ec55c
SPL ID: b48fb85d-87f5-0c70-e053-2a95a90a7011
Version: 4
Effective date: 2020-11-20
Source export date: 2026-10-27
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/2026-10-27/a758d73d4d838a965005e6adf01b928e2da86f99be0f8bbaeeb95f3b7acbe418/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:59:17

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	209786	derived:openfda.application_number
application number		ANDA209786	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	43386-168-01	openfda.package_ndc
ndc	package	43386-169-01	openfda.package_ndc
ndc	product	43386-169	openfda.product_ndc
ndc	product	43386-168	openfda.product_ndc
ndc11	package	43386016901	derived:openfda.package_ndc
ndc11	package	43386016801	derived:openfda.package_ndc
rxcui		314182	openfda.rxcui
rxcui		312515	openfda.rxcui
spl id		b48fb85d-87f5-0c70-e053-2a95a90a7011	id
spl set id		28c49165-d8c9-443a-b000-953b8e1ec55c	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 if administered undiluted. 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 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.