Phospha 250 Neutral

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include numbness or tingly feeling, muscle stiffness or limp feeling, loss of movement, confusion, heavy feeling in your legs, irregular heartbeats, or feeling like you might pass out.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe or ongoing diarrhea;

• seizures (convulsion);

• shortness of breath; or

• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

• nausea, vomiting, stomach pain, diarrhea;

• bone or joint pain;

• headache, dizziness, tired feeling;

• muscle pain or weakness;

• increased thirst; or

• numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with potassium phosphate and sodium phosphate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

This section provides information on the proper use of a number of products that contain potassium and sodium phosphate. It may not be specific to Phospha 250 Neutral. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take the tablet with a full (8 ounce) glass of water. Take it with meals and at bedtime, unless your doctor tells you differently.

If you are taking aluminum, magnesium, or calcium-containing antacids, do not take them at the same time that you take this medicine. This may keep the phosphate supplement from working properly.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For phosphate supplement:
    • Adults—One or two tablets four times a day.
    • Teenagers and children 4 years of age and older—One tablet four times a day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Upset stomach or throwing up.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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 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.

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.

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

is an orally administered medical food for use only under medical supervision for the dietary management of hypophosphatemia.

Manufactured for:
Rising Pharmaceuticals, Inc.
3 Pearl Court
Allendale, NJ 07 401

Manufactured by:
Mirror Pharmaceuticals LLC.
Fairfield, NJ 07004

Applies to potassium phosphate / sodium phosphate: oral tablet

Along with its needed effects, potassium phosphate / sodium phosphate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking potassium phosphate / sodium phosphate:

• Bone pain
• convulsions
• decreased urine output
• dizziness
• fast or irregular heartbeat
• headache
• joint pain
• mental confusion
• muscle cramps
• numbness or tingling around the lips
• numbness, tingling, pain, or weakness of the hands or feet
• shortness of breath
• swelling of the feet or lower legs
• troubled breathing
• unusual thirst
• unusual tiredness or weakness
• unusual weight gain
• weakness or heaviness of the legs

Some side effects of potassium phosphate / sodium phosphate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• nausea
• stomach pain
• vomiting