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

  • NDC Code(s): 0121-0595-15, 0121-0595-16, 0121-0595-30
  • Packager: Pharmaceutical Associates, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/12

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  • SPL UNCLASSIFIED SECTION

    A Sugar-Free Systemic Alkalizer

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  • 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 Dihydrate 500 mg (0.34 Molar)
    CITRIC ACID Monohydrate 334 mg (0.32 Molar)

    Each mL contains 1 mEq sodium ion and is equivalent to 1 mEq bicarbonate (HCO3).

    INACTIVE INGREDIENTS: Flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.

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  • 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.

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  • 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 administered for long periods.

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  • CONTRAINDICATIONS

    Patients on sodium-restricted diets or with severe renal impairment.

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  • PRECAUTIONS

    Sodium Citrate and Citric 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.

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  • 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.

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  • OVERDOSAGE

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

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  • DOSAGE AND ADMINISTRATION

    Sodium Citrate and Citric Acid Oral Solution USP should be taken diluted in water, followed by additional water, if desired. SHAKE WELL BEFORE USING.

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  • For Systemic Alkalization

    Usual Adult Dose

    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.

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  • As a neutralizing buffer

    3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician.

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  • HOW SUPPLIED

    Sodium Citrate and Citric Acid Oral Solution USP (colorless, grape flavor) is supplied in the following oral dosage forms: NDC 0121-0595-16 (16 fl oz bottles), NDC 0121-0595-15 (Unit dose cups of 15 mL, 10 × 10's) and NDC 0121-0595-30 (Unit dose cups of 30 mL, 10 × 10's).

    STORAGE

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

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  • SPL UNCLASSIFIED SECTION

    Rx ONLY

    Manufactured By:
    Pharmaceutical Associates, Inc.
    Greenville, SC 29605

    NDC 0121-0595

    05950199      R01/99

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  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 0121-0595-16
    NSN 6505-01-097-4766

    Sodium Citrate
    and Citric Acid
    Oral Solution USP

    500 mg/334 mg per 5 mL

    A SUGAR-FREE SYSTEMIC ALKALIZER

    Each teaspoonful (5 mL) contains:
    Sodium Citrate Dihydrate                     500 mg
    Citric Acid Monohydrate                     334 mg
    Each mL provides 1 mEq Sodium Ion and is
    equivalent to 1 mEq Bicarbonate (HCO3).

    Rx ONLY

    16 fl oz (473 mL)

    pai
    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    SODIUM CITRATE AND CITRIC ACID 
    sodium citrate and citric acid monohydrate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0121-0595
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CITRATE (ANHYDROUS CITRIC ACID) SODIUM CITRATE 500 mg  in 5 mL
    CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) CITRIC ACID MONOHYDRATE 334 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0121-0595-16 473 mL in 1 BOTTLE
    2 NDC:0121-0595-15 10 in 1 CASE
    2 10 in 1 TRAY
    2 15 mL in 1 CUP, UNIT-DOSE
    3 NDC:0121-0595-30 10 in 1 CASE
    3 10 in 1 TRAY
    3 30 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/01/1969
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaceutical Associates, Inc. 097630693 MANUFACTURE(0121-0595)
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