Label: SODIUM CITRATE AND CITRIC ACID- sodium citrate and citric acid monohydrate solution

  • NDC Code(s): 69367-320-16
  • 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 27, 2021

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  • SPL UNCLASSIFIED SECTION

    Rx Only
    NDC 69367-320-16

  • 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 Dihydrate500 mg
    Citric Acid Monohydrate334 mg

    Each mL contains 1 mEq Sodium Ion, and is equivalent to 1 mEq Bicarbonate (HCO3 ).

    INACTIVE INGREDIENTS: grape flavor, purified water, sodium benzoate, sodium saccharin, sorbitol solution.

  • 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.

  • 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 a administered for long periods.

  • CONTRAINDICATIONS

    Contraindicated in patients with sodium-restricted diets, with severe renal impairment, or known hypersensitivity to any of the ingredients.

  • WARNINGS

    Do not exceed recommended dosage. Discontinue use if adverse reactions occur.

  • PRECAUTIONS

    Sodium Citrate and Citrict 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

  • 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.

  • OVERDOSAGE

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

  • DOSAGE AND ADMINISTRATION

    Sodium Citrate and Citric Acid Oral Solution USP 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.

  • HOW SUPPLIED

    Sodium Citrate and Citric Acid Oral Solution USP is a (colorless, grape flavor) solution and is supplied in the following oral dosage form:

    NDC 69367-320-16 (16 fl oz bottles).

    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, contact 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: 69367-320-16
    Rx Only

    Sodium Citrate
    and Citric Acid
    Oral Solution USP

    500 mg/334 mg per 5 mL

    A SUGAR-FREE
    SYSTEMIC ALKALIZER

    EACH TEASPOONFUL (5mL) CONTAINS:
    SODIUM CITRATE DIHYDRATE
    500 mg
    CITRIC ACID MONOHYDRATE
    334 mg

    Each mL contains 1 mEq Sodium Ion,
    and is equivalent to 1 mEq
    Bicarbonate (HCO3).

    SHAKE WELL BEFORE USE

    16 FL OZ (473 mL)

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SODIUM CITRATE AND CITRIC ACID 
    sodium citrate and citric acid monohydrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69367-320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE, UNSPECIFIED FORM500 mg  in 5 mL
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID334 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-320-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER07/20/2021
    Labeler - Westminster Pharmaceuticals, LLC (079516651)