Label: TRICITRATES- potassium citrate, sodium citrate, and citric acid monohydrate solution

  • NDC Code(s): 0121-0677-16
  • Packager: PAI Holdings, LLC dba PAI Pharma
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 15, 2024

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  • SPL UNCLASSIFIED SECTION
    Rx ONLY
  • DESCRIPTION
    Tricitrates - SF Oral Solution is a stable and pleasant-tasting oral systemic alkalizer containing potassium citrate, sodium citrate, and citric acid in a sugar-free ...
  • 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 ...
  • INDICATIONS AND ADVANTAGES
    Tricitrates - SF Oral Solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in ...
  • 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 ...
  • 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 ...
  • ADVERSE REACTIONS
    Tricitrates - SF Oral Solution is generally well tolerated without any unpleasant side effects when given in recommended doses to patients with normal renal function and ...
  • DOSAGE AND ADMINISTRATION
    Tricitrates - SF Oral Solution should be taken diluted in water, followed by additional water, if desired. Palatability is enhanced if chilled before taking ...
  • 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 ...
  • HOW SUPPLIED
    Tricitrates - SF Oral Solution (orange colored, raspberry flavored) is supplied in the following oral dosage form: NDC 0121-0677-16:    16 fl oz (473 ...
  • SPL UNCLASSIFIED SECTION
    Manufactured By - Pharmaceutical Associates, Inc. Greenville, SC 29605 - R08/22
  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
    NDC 0121-0677-16 - Tricitrates SF - Oral Solution - 550 mg/500 mg/334 mg per 5 mL - A SUGAR-FREE SYSTEMIC ALKALIZER - Each teaspoonful (5 mL) contains ...
  • INGREDIENTS AND APPEARANCE
    Product Information