PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL - 15 mL Unit Dose Cup Label Delivers 15 mL NDC 0121-0595-15 S ODIUM C ITRATE and C ITRIC A CID O RAL S OLUTION USP (sugar Free) 1.5 g/1 g per 15 mL SHAKE WELL-DILUTE AS DIRECTED FOR INSTITUTIONAL USE ONLY Rx ONLYPHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT F05951501

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS Sodium Citrate and Citric Acid Oral Solution USP is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE Sodium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively. Sodium Citrate and Citric Acid Oral Solution USP is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION Sodium Citrate and Citric Acid Oral Solution USP should be taken diluted in water, followed by additional water, if desired. SHAKE WELL BEFORE USING.

SPL UNCLASSIFIED SECTION.


Rx ONLY Manufactured By: Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R06/16

HOW SUPPLIED SECTION.


HOW SUPPLIED Sodium Citrate and Citric Acid Oral Solution USP (colorless, grape flavor) is supplied in the following oral dosage forms: NDC 0121-0595-16: 16 fl oz (473 mL) bottle NDC 0121-0595-15: 15 mL unit dose cup NDC 0121-0595-00: Case contains 100 unit dose cups of 15 mL (0121-0595-15) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1190-30: 30 mL unit dose cup NDC 0121-1190-00: Case contains 100 unit dose cups of 30 mL (0121-1190-30) packaged in 10trays of 10 unit dose cups each.

DESCRIPTION SECTION.


DESCRIPTION Sodium Citrate and Citric Acid Oral Solution USP is a stable and pleasant-tasting systemic alkalizer containing sodium citrate and citric acid in a sugar-free base. It is a nonparticulate neutralizing buffer. Sodium Citrate and Citric Acid Oral Solution USP contains in each teaspoonful (5 mL): SODIUM CITRATE Dihydrate 500 mg (0.34 Molar) CITRIC ACID Monohydrate 334 mg (0.32 Molar) Each mL contains 1 mEq sodium ion and is equivalent to 1 mEq bicarbonate (HCO3). INACTIVE INGREDIENTS: Flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.

OVERDOSAGE SECTION.


OVERDOSAGE Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions.

PRECAUTIONS SECTION.


PRECAUTIONS Sodium Citrate and Citric Acid Oral Solution USP should be used with caution by patients with low urinary output unless under the supervision of a physician. This product should not be administered concurrently with aluminum-based antacids. Patients should be directed to dilute adequately with water and preferably, to take each dose after meals to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary edema, and toxemia of pregnancy. Periodic examinations and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.

STORAGE AND HANDLING SECTION.


STORAGE: Keep tightly closed. Store at controlled room temperature, 20-25C (68-77F). Protect from freezing.

CLINICAL PHARMACOLOGY SECTION.


CLINICAL PHARMACOLOGY Sodium citrate is absorbed and metabolized to sodium bicarbonate, thus acting as a systemic alkalizer. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of sodium citrate is excreted in the urine unchanged.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS Patients on sodium-restricted diets or with severe renal impairment.