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.
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.
Store at controlled room temperature 20°-25°C (68°-77°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken. Rx only
Rx only
PHOSPHA 250™ NEUTRAL
Supplies 250 mg of phosphorus per tablet
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).
Purified Water, Lactose Monohydrate, Sodium Starch Glycolate, Polyvinyl Pyrrolidone, Magnesium Stearate, Hydroxypropyl methylcellulose, Polyethylene Glycol 400, Titanium dioxide.
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. In 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 excretion of 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.
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.
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.
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 extra-skeletal calcification.
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.
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.
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.
No long term or reproduction studies in animals or humans have been performed with PHOSPHA 250 TM NEUTRAL to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.
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.
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.
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.
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.
White, film-coated, capsule-shaped tablet, debossed with RIS 104 on each tablet.
Unit dose packages of 30 (5 x 6) NDC 68084-764-25.
Store at controlled room temperature 20°-25°C (68°-77°F).
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Rx only
Phospha 250 TM Neutral is an orally administered medical food for use only under medical supervision for the dietary management of hypophosphatemia.
American Health Packaging unit dose blisters (see
How Supplied section) contain drug product from Rising Pharmaceuticals, Inc. as follows:
(250 mg / 30UD) NDC 68084-764-25 packaged from NDC 64980-104
Distributed by:
American Health Packaging
Columbus, OH 43217
8276425/1115OS
NDC 68084- 764-25
Phospha 250
TM
Neutral
250 mg
30 Tablets (5 x 6) Rx Only
Phosphorus supplement which supplies 250 mg per tablet.
DESCRIPTION: 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 sodium
(13.0 mEq), and 45 mg of potassium (1 .1 mEq).
OTHER INGREDIENTS: Purified Water, Lactose, Monohydrate,
Sodium Starch Glycolate, Polyvinyl Pyrrolidone, Magnesium
Stearate, Hydroxypropyl methylcellulose, Polyethylene Glycol 400,
Titanium dioxide.
DOSAGE AND ADMINISTRATION: Phospha 250™ Neutral
tablets should be taken with a full glass of water, with meals and at
bedtime. See package insert for full prescribing information.
Adults: One or two tablets four times daily;
Pediatric Patients
over 4 years of age:
One tablet four times daily. For Pediatric
Patients under 4 years of age, use only as directed by a physician.
STORAGE: Store at controlled room temperature, 20° to 25°C (68°
to 77°F).
IDENTITY: Phospha 250™ Neutral is an orally administered
medical food for use only under medical supervision for the dietary
management of hypophosphatemia.
To report a serious adverse event contact American Health
Packaging at: 1-800-707-4621.
Keep this and all drugs out of reach of children.
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from
NDC # 64980-104, Rising Pharmaceuticals, Inc.
Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217
076425
0276425/0119
Phospha 250
TM Neutral
phosphorus supplement
which supplies
250 mg
per tablet
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | DataBar Limited | (01)00368084764257 | GTIN-14: 00368084764257 GTIN-12: 368084764257 UPC-A: 368084764257 EAN-13: 0368084764257 GTIN storage (14 digits): 00368084764257 | Phospha 250 Neutral Supplement Carton.jpg |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68084-764-25 | EA - Each | 68084-764 | 5b315cbe-a6fb-4bd6-a061-36dbb62cfdfb | 1 | 2014-07-02 |
| 68084-764-95 | EA - Each | 68084-764 | a0df5feb-1950-4863-96d1-99fee75faed8 | 1 | 2014-07-02 |
| 64980-104-01 | EA - Each | 64980-104 | dee9f175-0864-43c2-8e6e-92abb64805b6 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| POTASSIUM PHOSPHATE, MONOBASIC | ACTIVE INGREDIENT | 4J9FJ0HL51 | 1 | |
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | ACTIVE INGREDIENT | 22ADO53M6F | 1 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | ACTIVE INGREDIENT | 593YOG76RN | 1 | |
| PHOSPHATE ION | ACTIVE MOIETY | NK08V8K8HR | 1 | |
| HYPROMELLOSE 2910 (15000 MPA.S) | INACTIVE INGREDIENT | 288VBX44JC | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68084-764 | 68084-764-95, 68084-764-25 |
| 64980-104 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET / ORAL | 193 mg | ||
| HYPROMELLOSE 2910 (15000 MPA.S) | HYPROMELLOSE 2910 (15000 MPA.S) | 288VBX44JC | TABLET / ORAL | 29 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate | DIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATE | Rising Pharma Holdings, Inc. | b01eac95-dbe3-4b21-a922-187e0fc8ad23 | 2026-04-07 | Adverse reactions | 64980-104 |
| 89162207-508f-55c0-e053-2a95a90ae36f | 09b3fdc2-38de-4a37-ac9b-d7eabb6db0f9 | 2019-05-17 | Adverse reactions | 89162207-508f-55c0-e053-2a95a90ae36f 09b3fdc2-38de-4a37-ac9b-d7eabb6db0f9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.