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Generic nameTRICITRATES
Labeler / manufacturerChartwell RX, LLC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC62135-438
Label effective date2025-04-28
Official product label reference
Tricitrates — Chartwell RX, LLC
This page contains 8 source sections for TRICITRATES, oral route. Label set 2a80ea6b-6334-4c33-a35e-a5cb2939fbcb, version 6.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
INDICATIONS AND ADVANTAGES Tricitrates oral solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urine 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 recommended dosage. It is highly palatable, pleasant tasting, and tolerable, even when administered for long periods. Potassium citrate and sodium citrate do not neutralize the gastric juice or disturb digestion.
Dosage and administration — label text
DOSAGE AND ADMINISTRATION Tricitratesoral solution should be taken diluted in water, followed by additional water, if desired. Palatability is enhanced if chilled before taking. Usual Adult Dose 3 to 6 teaspoonfuls (15 to 30 mL), diluted in water, four times a day, after meals and at bedtime, or as directed by a physician. Usual Pediatric Dose 1 to 3 teaspoonfuls (5 to 15 mL), diluted in water, four times a day, after meals and at bedtime, or as directed by a physician. Usual Dosage Range 2 to 3 teaspoonfuls (10 to 15 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 6.5-7.4. 3 to 4 teaspoonfuls (15 to 20 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 7.0-7.6 throughout most of the 24 hours without unpleasant side effects. To check urine pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.
Contraindications
CONTRAINDICATIONS Severe renal impairment with oliguria or azotemia, untreated Addison's disease, or severe myocardial damage. In certain situations, when patients are on a sodium-restricted diet, the use of potassium citrate may be preferable; or, when patients are on a potassium-restricted diet, the use of sodium citrate may be preferable.
Warnings and precautions
PRECAUTIONS AND WARNINGS Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of a physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and, preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt preparations and to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination 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.
Adverse reactions
ADVERSE REACTIONS Tricitrates oral 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 hyperkalemia or alkalosis, especially in the presence of hypocalcemia. Potassium intoxication causes listlessness, weakness, mental confusion, and tingling of extremities.
Product description
DESCRIPTION Tricitrates Oral Solution, USP is a stable orange colored and cherry flavored oral systemic alkalizer containing potassium citrate, sodium citrate, and citric acid in a sugar-free, non-alcoholic base. Tricitrates Oral Solution, USP contains in each teaspoonful (5 mL): Potassium Citrate Monohydrate, USP 550 mg Sodium Citrate Dihydrate, USP 500 mg Citric Acid Monohydrate, USP 334 mg Each mL contains 1 mEq potassium ion and 1 mEq sodium ion and is equivalent to 2 mEq bicarbonate (HCO 3 ). Inactive Ingredients: saccharin sodium, sodium benzoate, sorbitol solution, FD&C yellow # 6, wild cherry flavor, and purified water. ACTIONS Potassium citrate and sodium citrate are absorbed and metabolized to potassium bicarbonate and sodium bicarbonate, thus acting as systemic alkalizers. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of the citrates are excreted in the urine unchanged.
Overdose information
OVERDOSAGE Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions. Overdosage with potassium salts may cause hyperkalemia and alkalosis, especially in the presence of renal disease.
Supply and packaging
HOW SUPPLIED Tricitrates Oral Solution, USP (orange colored, cherry flavored) is supplied in the following oral dosage form: 16 fl oz (473 mL) bottles NDC 62135-438-47 5 mL Unit-Dose Cup NDC 62135-438-05 20 Unit-Dose Cups of 5 mL NDC 62135-438-24 STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing. SHAKE WELL BEFORE USING. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71160 Rev. 04/2025
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.