{"adverse_reactions":["ADVERSE REACTIONS Sodium Citrate-Citric Acid Solution 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."],"clinical_pharmacology":["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":["CONTRAINDICATIONS Contraindicated in patients with sodium- restricted diets, with severe renal impairment, or known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION Sodium Citrate-Citric Acid Solution 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-Citric Acid Solution contains in each teaspoonful (5 mL): Sodium Citrate Dihydrate ............................ 500 mg Citric Acid Monohydrate ............................. 334 mg Each mL contains 1 mEq Sodium Ion, and is equivalent to 1 mEq Bicarbonate (HC03)."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Sodium Citrate-Citric Acid Solution should be administered by diluting in water, followed by additional water, if desired. SHAKE WELL BEFORE USING. For Systemic Alkalization: Usual Adult Dosage: 2 to 6 teaspoonfuls (10 to 30 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. Usual Pediatric Dose: 1 to 3 teaspoonfuls (5 to 15 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician. As a neutralizing buffer: 3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician."],"effective_time":"20160303","how_supplied":["HOW SUPPLIED Sodium Citrate-Citric Acid Solution is a (colorless, grape flavor) solution and is supplied in the following oral dosage form: NDC 58657-410-16 (16 fl oz bottles)."],"id":"2d286dd5-ba81-4aa4-e054-00144ff88e88","inactive_ingredient":["INACTIVE INGREDIENTS: propylene glycol, sorbitol, polyethylene glycol 400, sodium benzoate, sodium saccharin, grape flavor, and purified water."],"indications_and_usage":["INDICATIONS AND USAGE Sodium Citrate-Citric Acid Solution 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-Citric Acid Solution 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."],"openfda":{},"overdosage":["OVERDOSAGE Overdosage with sodium salts may cause diarrhea, nausea, and vomiting, hypernoia, and convulsions."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 58657-410-16 Sodium Citrate- Citric Acid Solution 500 mg/334 mg per 5 mL Rx Only SHAKE WELL BEFORE USE 16 fl oz (473 mL ) PRINCIPAL DISPLAY PANEL NDC 58657-410-16 Sodium Citrate- Citric Acid Solution 500 mg/334 mg per 5 mL Rx Only SHAKE WELL BEFORE USE 16 fl oz (473 mL)"],"precautions":["PRECAUTIONS Sodium Citrate-Citric Acid Solution 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."],"set_id":"2b6fc331-e2d4-1536-e054-00144ff88e88","spl_product_data_elements":["Sodium Citrate-Citric Acid Trisodium Citrate Dihydrate and Citric Acid Monohydrate SODIUM CATION PROPYLENE GLYCOL SORBITOL POLYETHYLENE GLYCOL 400 SODIUM BENZOATE SACCHARIN SODIUM WATER TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID CITRIC ACID MONOHYDRATE ANHYDROUS CITRIC ACID"],"spl_unclassified_section":["Rx Only NDC 58657-310-16"],"storage_and_handling":["STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing. To report a serious adverse event or to obtain product information, call (877) 250-3427. Distributed by: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev. 10/2014"],"version":"3","warnings":["WARNINGS Do not exceed recommended dosage. Discontinue use if adverse reactions occur."]}