K Phos

Manufacturer
Carilion Materials Management
Effective date
2014-09-29
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:22:22

Label at a glance#

ProductK Phos Original
Active ingredientPotassium Phosphate, Monobasic
Label structure10 sections

Dosage and administration

Two tablets dissolved in 6-8 oz. of water 4 times daily with meals and at bedtime. For best results, let the tablets soak in water for 2 to 5 minutes, or more if necessary, and stir. If any tablet particles remain undissolved, they may be crushed and stirred vigorously to speed dissolution.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Each tablet contains potassium acid phosphate 500 mg. Each tablet yields approximately 114 mg of phosphorus and 144 mg of potassium or 3.7 mEq.

Inactive ingredients: Magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid.

ACTIONS

MECHANISM OF ACTION SECTION

K-PHOS® ORIGINAL is a highly effective sodium-free urinary acidifier.

INDICATONS AND USAGE

INDICATIONS & USAGE SECTION

For use in patients with elevated urinary pH. K-PHOS® ORIGINAL helps keep calcium soluble and reduces odor and rash caused by ammoniacal urine. Also, by acidifying the urine, it increases the antibacterial activity of methenamine mandelate and methenamine hippurate.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

This product is contraindicated in patients with infected phosphate stones; in patients with severely impaired renal function (less than 30% of normal) and in the presence of hyperphosphatemia and hyperkalemia.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

This product contains potassium and should be used with caution if regulation of this element is desired. Occasionally, some individuals may experience a mild laxative effect during the first few days of phosphate therapy. If laxation persists to an unpleasant degree, reduce the daily dosage until this effect subsides or, if necessary, discontinue the use of this product.

Caution should be exercised when prescribing this product in the following conditions: Cardiac disease (particularly in digitalized patients); severe adrenal insufficiency (Addison's disease); acute dehydration; severe renal insufficiency or chronic renal disease; extensive tissue breakdown (such as severe burns); myotonia congenita; hypoparathyroidism; and acute pancreatitis. Rickets may benefit from phosphate therapy, but caution should be exercised. High serum phosphate levels may increase the incidence of extra-skeletal calcification.

Information for Patients

INFORMATION FOR PATIENTS SECTION

Patients with kidney stones may pass old stones when phosphate therapy is started and should be warned of this possibility. Patients should be advised to avoid the use of antacids containing aluminum, calcium, or magnesium, which may prevent the absorption of phosphate. To assure against gastrointestinal injury associated with oral ingestion of concentrated potassium salt preparations, patients should be instructed to dissolve tablets completely in an appropriate amount of water before taking.

Laboratory Tests

LABORATORY TESTS SECTION

Careful monitoring of renal function and serum calcium, phosphorus and potassium may be required at periodic intervals during potassium phosphate therapy. Other tests may be warranted in some patients, depending on conditions.

Drug Interactions

DRUG INTERACTIONS SECTION

The use of antacids containing magnesium, calcium, or aluminum in conjunction with phosphate preparations may bind the phosphate and prevent its absorption. Potassium-containing medications or potassium-sparing diuretics may cause hyperkalemia when used concurrently with potassium salts. Patients should have serum potassium level determinations at periodic intervals. Concurrent use of salicylates may lead to increased serum salicylate levels since excretion of salicylates is reduced in acidified urine. Serum salicylate levels should be closely monitored to avoid toxicity.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

No long-term or reproduction studies in animals or humans have been performed with K-PHOS® ORIGINAL to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects

TERATOGENIC EFFECTS SECTION

Pregnancy Category C

SPL UNCLASSIFIED SECTION

Animal reproduction studies have not been conducted with K-PHOS® ORIGINAL. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers

NURSING MOTHERS SECTION

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Gastrointestinal upset (diarrhea, nausea, stomach pain, and vomiting) may occur with the use of potassium phosphate. Also, bone and joint pain (possible phosphate-induced osteomalacia) could occur. The following adverse effects may be observed with potassium administration: irregular heartbeat; dizziness; mental confusion; weakness or heaviness of legs; unusual tiredness; muscle cramps; numbness, tingling, pain, or weakness in hands or feet; numbness or tingling around lips; shortness of breath or troubled breathing.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Two tablets dissolved in 6-8 oz. of water 4 times daily with meals and at bedtime. For best results, let the tablets soak in water for 2 to 5 minutes, or more if necessary, and stir. If any tablet particles remain undissolved, they may be crushed and stirred vigorously to speed dissolution.

HOW SUPPLIED

HOW SUPPLIED SECTION

NDC:68151-2193-0 in a PACKAGE of 1 TABLET, SOLUBLES

STORAGE

STORAGE AND HANDLING SECTION

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Dispense in tight, light-resistant containers with child-resistant closures.

SPL UNCLASSIFIED SECTION

BEACH PHARMACEUTICALS, Div. of Beach Products, Inc., Tampa, FL 33611

Rev: 07/09B

Potassium Acid Phosphate 500 mg tabs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101778K-Phos 500 MG Tablet for Oral SolutionPSN2
1101778monobasic potassium phosphate 0.0408 MEQ/ML Oral Solution [K-Phos]SBD2
1101775monobasic potassium phosphate 0.0408 MEQ/ML Oral SolutionSCD2
1101778K-Phos 0.0408 MEQ/ML Oral SolutionSY2
1101778K-Phos 500 MG Tablet for Oral SolutionSY2
1101775Monobasic K+ phosphate 0.0408 MEQ/ML Oral SolutionSY2
1101778Monobasic K+ phosphate 0.0408 MEQ/ML Oral Solution [K-Phos]SY2
1101775Monobasic Pot phosphate 0.0408 MEQ/ML Oral SolutionSY2
1101778Monobasic Pot phosphate 0.0408 MEQ/ML Oral Solution [K-Phos]SY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
POTASSIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-2193-02020-01-31C16284748780-19d75b9d0-c472-f424-e053-dadaa90a57ceK-PHOS® ORIGINAL Potassium Acid Phosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2193-0K Phos Original1 in 1 PACKAGETABLET, SOLUBLE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2193K PHOS ORIGINAL (POTASSIUM PHOSPHATE, MONOBASIC) TABLET, SOLUBLE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20160617_0d128959-ddfe-4255-a5fe-6e6c09764d82.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0486-1111-01EA - Each0486-111168e8aa07-2183-46a2-aec1-b0652557b50b12014-10-03
0486-1111-05EA - Each0486-1111122d5d86-a9e7-45e4-a630-755b595211eb12014-10-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68151-219368151-2193-0
0486-1111

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
K Phos OriginalPOTASSIUM PHOSPHATE, MONOBASICBeach Products, Inc.04557ab3-6d21-49b4-b849-744c75b8a6302023-02-23Adverse reactionsExact identifier
ndc (product): 0486-1111
01e77301-afcb-421b-b2c3-58ad1fbef7b80d128959-ddfe-4255-a5fe-6e6c09764d822014-09-29Adverse reactionsExact identifier
spl id: 01e77301-afcb-421b-b2c3-58ad1fbef7b8
spl set id: 0d128959-ddfe-4255-a5fe-6e6c09764d82

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.