Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate

INDICATIONS AND USAGE 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.

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.

Drug Interactions: 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.

Pregnancy: 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: 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 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.