Label: POTASSIUM CITRATE AND CITRIC ACID- potassium citrate and citric acid monohydrate solution

  • NDC Code(s): 69367-321-16
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 28, 2021

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    NDC 69367-321-16

  • DESCRIPTION

    Potassium Citrate and Citric Acid Oral Solution USP is a stable and pleasant-tasting oral systemic alkalizer containing potassium citrate and citric acid in a sugar-free, non alcoholic base.

    Potassium Citrate and Citric Acid Oral Solution USP contains in each teaspoonful (5 mL):

    Potassium Citrate Monohydrate1100 mg
    Citric Acid Monohydrate334 mg

    Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq bicarbonate (HCO3).

    INACTIVE INGREDIENTS

    cherry flavor, FD&C red #40, purified water, sodium benzoate, sodium saccharin, sorbitol solution.

    ACTIONS

    Potassium citrate is absorbed and metabolized to potassium 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 the potassium citrate is excreted in the urine unchanged.

  • INDICATIONS AND USAGE

    Potassium Citrate and Citric Acid Oral Solution USP 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, especially when the administration of sodium salts is undesirable or contraindicated. 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 where the administration of potassium citrate may be preferable. This product is highly 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 recommended dosage. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium citrate does not neutralize the gastric juice or disturb digestion.

  • CONTRAINDICATIONS

    Severe renal impairment with oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, and hyperkalemia from any cause. Known hypersensitivity to any ingredient.

  • WARNINGS

    There have been several reports, published and unpublished, concerning nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts. These lesions may occur with enteric-coated potassium tablets alone or when they are used with nonenteric-coated thiazides, or certain other oral diuretics. These small-bowel lesions have caused obstruction, hemorrhage, and perforation. Surgery was frequently required and deaths have occurred. Based on a large survey of physicians and hospitals, both United States and foreign, the incidence of these lesions is low, and a causal relationship in man has not been definitely established. Available information tends to implicate enteric-coated potassium salts, although lesions of this type also occur spontaneously. Therefore, coated potassium-containing formulations should be administered only when indicated, and should be discontinued immediately if abdominal pain, distention, nausea, vomiting, or gastrointestinal bleeding occur.

    Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Do not exceed recommended dosage.

    Discontinue use if adverse reaction occurs.

  • PRECAUTIONS

    Should be used with caution by patients with low urinary output unless under the supervision of a physician. As with all liquids containing a high concentration of potassium, patients should be directed to dilute adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations; and preferably, to take each dose after meals to avoid saline laxative effect.

  • ADVERSE REACTIONS

    Potassium 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 hyperkalemia or alkalosis. Potassium is highly 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 recommended dosage. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium citrate does not neutralize the gastric juice or disturb digestion. intoxication causes restlessness, weakness, mental confusion, tingling of extremities, and other symptoms associated with a high concentration of potassium in the serum. Periodic determinations of serum electrolytes should be carried out in those patients with renal disease in order to avoid these complications. Hyperkalemia may exhibit the following electrocardiographic abnormalities: Disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves, etc.

  • OVERDOSAGE

    The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result (see Contraindications and Warnings). Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours.

    TREATMENT OF HYPERKALEMIA

    Should hyperkalemia occur, treatment measures include the following: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 mL/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis, or peritoneal dialysis. In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the plasma potassium concentration can produce digitalis toxicity.

  • DOSAGE AND ADMINISTRATION

    Potassium Citrate and Citric Acid Oral Solution USP should be taken diluted in water according to directions, followed by additional water, if desired. Palatability is enhanced if chilled before taking.

    Proper dilution may help prevent gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations.

    Usual Adult Dose: 3 to 6 teaspoonfuls (15 to 30 mL), diluted with 1 glass 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 with 1/2 glass of water, after meals and at bedtime, or as directed by a physician.

    Usual Dosage Range: 2 to 3 teaspoonfuls (10 to 15 mL), diluted with a glassful of water, taken four times a day. Potassium Citrate and Citric Acid Oral Solution USP, diluted with a glassful of 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 urinary pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.

  • HOW SUPPLIED

    Potassium Citrate and Citric Acid Oral Solution USP is a (red colored; cherry flavored) oral solution and is supplied in the following oral dosage form:

    NDC 69367-321-16 (16 fl oz bottles).

    STORAGE

    Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing.

    Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

    Dispense in a tight, light-resistant container as defined in the USP/NF with a childresistant closure.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    Call your doctor for medical advice about side effects. You may report side effects to Westminster Pharmaceuticals, LLC at 1-844-221-7294.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Westminster Pharmaceuticals LLC.
    Nashville TN, 37217
    Rev. 04/21

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC: 69367-321-16
    Rx Only

    Potassium Citrate
    and Citric Acid
    Oral Solution USP

    1100 mg/334 mg per 5 mL

    A SUGAR-FREE
    SYSTEMIC ALKALIZER

    EACH TEASPOONFUL (5mL) CONTAINS:
    POTASSIUM CITRATE MONOHYDRATE
    1100 mg
    CITRIC ACID MONOHYDRATE
    334 mg

    Each mL contains 2 mEq Potassium Ion,
    and is equivalent to 2 mEq
    Bicarbonate (HCO3).

    SHAKE WELL BEFORE USE

    16 FL OZ (473 mL)

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    POTASSIUM CITRATE AND CITRIC ACID 
    potassium citrate and citric acid monohydrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69367-321
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) POTASSIUM CITRATE1100 mg  in 5 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID334 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-321-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER07/21/2021
    Labeler - Westminster Pharmaceuticals, LLC (079516651)