PHOSPHA 250™ NEUTRAL Supplies 250 mg of phosphorus per tablet

Manufacturer
Rising Pharma Holdings, Inc. | Ingenus Pharmaceuticals NJ, LLC
Effective date
2026-03-25
Label type
Human Prescription Drug Label
Version
1
Source
full-release
Hydrated at
2026-05-31 22:11:53

Label at a glance#

ProductPHOSPHA 250 NEUTRAL
Active ingredientSODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Label structure12 sections

Indications and uses

PHOSPHA 250 TM NEUTRAL increases urinary phosphate and pyrophosphate. As a phosphorus supplement, each tablet supplies 25% of the U.S. Recommended Daily Allowance (U.S. RDA) of phosphorus for adults and children over 4 years of age.

Dosage and administration

PHOSPHA 250 TM NEUTRAL tablets should be taken with a full glass of water, with meals and at bedtime. Adults: One or two tablets, four times daily; Pediatric patients over 4 years of age: One tablet four times daily. Pediatric Patients under 4 years of age: Use only as directed by physician.

Storage and handling

Keep tightly closed. Store at controlled room temperature 20°-25°C (68°-77°F}. Dispense in tight, light-resistant containers with child resistant closures.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Each tablet contains 852 mg dibasic sodium phosphate anhydrous, 155 mg monobasic potassium phosphate, and 130 mg monobasic sodium phosphate monohydrate. Each tablet yields approximately 250 mg of phosphorus, 298 mg of sodium (13.0 mEq) and 45 mg of potassium (1 .1 mEq).

OTHER INGREDIENTS

SPL UNCLASSIFIED SECTION

Purified Water, Lactose Monohydrate, Sodium Starch Glycolate, Polyvinyl Pyrrolidone, Magnesium Stearate, Hydroxypropyl methylcellulose, Triacetin, Titanium dioxide.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Phosphorus has a number of important functions in the biochemistry of the body. The bulk of the body's phosphorus is located in the bones, where it plays a key role in osteoblastic and osteoclastic activities. Enzymatically catalyzed phosphate-transfer reactions are numerous and vital in the metabolism of carbohydrate, lipid and protein, and a proper concentration of the anion is of primary importance in assuring an orderly biochemical sequence. ln addition, phosphorus plays an important role in modifying steady-state tissue concentrations of calcium. Phosphate ions are important buffers of the intracellular fluid, and also play a primary role in the renal excretionof the hydrogen ion.

Oral administration of inorganic phosphates increases serum phosphate levels. Phosphates lower urinary calcium levels in idiopathic hypercalciuria.

In general, in adults, about two thirds of the ingested phosphate in absorbed from the bowel, most of which is rapidly excreted into the urine.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

PHOSPHA 250TM NEUTRAL increases urinary phosphate and pyrophosphate. As a phosphorus supplement, each tablet supplies 25% of the U.S. Recommended Daily Allowance (U.S. RDA) of phosphorus for adults and children over 4 years of age.

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.

PRECAUTIONS

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

General: This product contains potassium and sodium and should be used with caution if regulation of these elements 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 dose until this effect subsides or, if necessary, discontinue the use of the 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; renal function impairment or chronic renal disease; extensive tissue breakdown (such as severe burns); myotonia congenita; cardiac failure; cirrhosis of the liver or severe hepatic disease; peripheral or pulmonary edema; hypernatremia; hypertension; toxemia of pregnancy; hypoparathyroidism; and acute pancreatitis. Rickets may benefit from phosphate therapy, but caution should be exercised. High serum phosphate levels may increase the incidence of extraskeletal calcification.

INFORMATION FOR PATIENTS SECTION

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, magnesium, or calcium which may prevent the absorption of phosphate.

LABORATORY TESTS SECTION

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

Drug Interactions:

DRUG INTERACTIONS SECTION

The use of antacids containing magnesium, aluminum, or calcium in conjunction with phosphate preparations may bind the phosphate and prevent its absorption. Concurrent use of antihypertensives, especially diazoxide, guanethidine, hydralazine, methyldopa, or rauwolfia alkaloid; or corticosteroids, especially mineralocorticoids or corticotropin with sodium phosphate may result in hypernatremia. Calcium-containing preparations and/or Vitamin D may antagonize the effects of phosphates in the treatment of hypercalcemia. Potassium-containing medication or potassium-sparing diuretics may cause hyperkalemia. Patients should have serum potassium level determinations at periodic intervals.

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 PHOSPHA 250TM NEUTRAL to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.

Pregnancy:

PREGNANCY SECTION

Teratogenic Effects. Pregnancy Class C. Animal reproduction studies have not been conducted with PHOSPHA 250 TM NEUTRAL. 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.

Pediatric Use:

PEDIATRIC USE SECTION

See DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

Gastrointestinal upset (diarrhea, nausea, stomach pain, and vomiting) may occur with phosphate therapy. Also, bone and joint pain (possible phosphate-induced osteomalacia) could occur. The following adverse effects may be observed (primarily from sodium or potassium): headaches; dizziness; mental confusion; seizures; weakness or heaviness of legs; unusual tiredness or weakness; muscle cramps; numbness, tingling, pain or weakness of hands or feet; numbness or tingling around lips; fast or irregular heartbeat; shortness of breath or troubled breathing; swelling of feet or lower legs; unusual weight gain; low urine output; unusual thirst.

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc., at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

PHOSPHA 250TM NEUTRAL tablets should be taken with a full glass of water, with meals and at bedtime.

Adults: One or two tablets, four times daily;

Pediatric patients over 4 years of age: One tablet four times daily.

Pediatric Patients under 4 years of age: Use only as directed by physician.

HOW SUPPLIED

HOW SUPPLIED SECTION

White, film-coated, capsule-shaped tablet, debossed with RIS 104 on each tablet.

NDC #64980-729-01
Bottles of 100 tablets

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

Manufactured by:
Ingenus Pharmaceuticals NJ, LLC
Fairfield, NJ 07004
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Rx only

555900               Rev: 02/2026

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY - 250 mg
NDC 64980-729-01

Phospha 250TM
Neutral

phosphourus supplement which supplies 250 mg per tablet

100 Tablets

Rx Only

phospha-container-labelphospha-container-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
656742Phospha 250 Neutral 852 MG / 155 MG / 130 MG Oral TabletPSN1
200251sodium phosphate, dibasic 852 MG / potassium phosphate, monobasic 155 MG / sodium phosphate, monobasic 130 MG Oral TabletPSN1
656742potassium phosphate 155 MG / sodium phosphate, dibasic 852 MG / sodium phosphate, monobasic 130 MG Oral Tablet [Phospha 250 Neutral]SBD1
200251potassium phosphate 155 MG / sodium phosphate, dibasic 852 MG / sodium phosphate, monobasic 130 MG Oral TabletSCD1
200251K+ phosphate 155 MG / Sodium Phosphate, Dibasic 852 MG / Sodium Phosphate, Monobasic 130 MG Oral TabletSY1
656742K+ phosphate 155 MG / Sodium Phosphate, Dibasic 852 MG / Sodium Phosphate, Monobasic 130 MG Oral Tablet [Phospha 250 Neutral]SY1
200251Pot phosphate 155 MG / Sodium Phosphate, Dibasic 852 MG / Sodium Phosphate, Monobasic 130 MG Oral TabletSY1
656742Pot phosphate 155 MG / Sodium Phosphate, Dibasic 852 MG / Sodium Phosphate, Monobasic 130 MG Oral Tablet [Phospha 250 Neutral]SY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130364980729017GTIN-13: 0364980729017
EAN-13: 0364980729017
GTIN-12: 364980729017
UPC-A: 364980729017
GTIN storage (14 digits): 00364980729017
phospha-container-label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-729-01PHOSPHA 250 NEUTRAL100 in 1 BOTTLETABLET1001

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64980-72964980-729-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
ndc (package): 64980-729-01
ndc (product): 64980-729
ndc11 (package): 64980072901
spl id: f6c34864-dbd6-436e-b1e5-b1feaa61696a
spl set id: 9432adfc-6add-4ab4-ae93-2e2daf348be2

Reported adverse events (FAERS/openFDA)#

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