Label: K PHOS ORIGINAL- potassium phosphate, monobasic tablet, soluble
- NDC Code(s): 0486-1111-01, 0486-1111-05
- Packager: Beach Products, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 23, 2023
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- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- ACTIONS
- INDICATONS AND USAGE
- CONTRAINDICATIONS
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PRECAUTIONS
General
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
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
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
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
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
Teratogenic Effects
Pregnancy Category C
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.
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ADVERSE REACTIONS
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
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
NDC 0486-1111-01
K-PHOS® Original
(Sodium-Free)
POTASSIUM ACID PHOSPHATEURINARY ACIDIFIER
Rx ONLY
100 TABLETS
Beach
PHARMACEUTICALS
PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label
NDC 0486-1111-05
K-PHOS® Original
(Sodium-Free)
POTASSIUM ACID PHOSPHATEURINARY ACIDIFIER
Rx ONLY
500 TABLETS
Beach
PHARMACEUTICALS
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INGREDIENTS AND APPEARANCE
K PHOS ORIGINAL
potassium phosphate, monobasic tablet, solubleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0486-1111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, MONOBASIC 500 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code BEACH;1111 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0486-1111-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/29/1977 2 NDC:0486-1111-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/29/1977 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/29/1977 Labeler - Beach Products, Inc. (032763633) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549200 manufacture(0486-1111)