NDC 0486-1111 K Phos Original
Potassium Phosphate, Monobasic Tablet, Soluble Oral

Product Information

Product Code0486-1111
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
K Phos Original
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Potassium Phosphate, Monobasic
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormTablet, Soluble - A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Beach Products, Inc.
Labeler Code0486
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
UNAPPROVED DRUG OTHER -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-29-1977
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)11 MM
Imprint(s)BEACH;1111
Score1

Product Packages

NDC 0486-1111-01

Package Description: 100 TABLET, SOLUBLE in 1 BOTTLE

Price per Unit: $0.46838 per EA

NDC 0486-1111-05

Package Description: 500 TABLET, SOLUBLE in 1 BOTTLE

Price per Unit: $0.46838 per EA

Product Details

K Phos Original is a human prescription drug product labeled by Beach Products, Inc.. The generic name of K Phos Original is potassium phosphate, monobasic. The product's dosage form is tablet, soluble and is administered via oral form.


What are K Phos Original Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)


* Please review the disclaimer below.

K Phos Original Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Rx ONLY

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

Rev: 07/09B


Description



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



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


Indicatons And Usage



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



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.


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 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.


Nursing Mothers



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



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



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



White, scored tablet with the name BEACH and the number 1111 imprinted on each tablet. Bottles of 100 (NDC 0486-1111-01) and bottles of 500 (NDC 0486-1111-05) tablets.


Storage



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

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


Principal Display Panel - 100 Tablet Bottle Label



NDC 0486-1111-01

K-PHOS® Original
(Sodium-Free)
POTASSIUM ACID PHOSPHATE

URINARY ACIDIFIER
Rx ONLY
100 TABLETS

Beach


* Please review the disclaimer below.