{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Sodium Citrate and Citric Acid SODIUM CITRATE and CITRIC ACID MONOHYDRATE WATER SODIUM CITRATE ANHYDROUS CITRIC ACID ANHYDROUS CITRIC ACID ANHYDROUS CITRIC ACID SORBITOL SUCRALOSE SODIUM BENZOATE"
      ],
      "description": [
        "DESCRIPTION Sodium Citrate and Citric Acid Oral Solu􀆟 on, USP is a stable and pleasant-tas􀆟 ng systemic alkalizer containing sodium citrate and citric acid in a sugar-free base. It is a non-par􀆟 culate neutralizing buff er. Sodium Citrate and Citric Acid Oral Solu􀆟 on, 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: grape fl avoring, purifi ed water, sodium benzoate, sorbitol and sucralose."
      ],
      "clinical_pharmacology": [
        "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": [
        "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."
      ],
      "contraindications": [
        "CONTRAINDICATIONS Patients on sodium-restricted diets or with severe renal impairment."
      ],
      "precautions": [
        "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."
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS Sodium citrate and citric acid oral solution on is generally well tolerated, without any unpleasant side eff ects, when given in recommended doses to patients with normal renal function on and urinary output. However, as with any alkalinizing agent, caution on must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia. To report SUSPECTED ADVERSE REACTIONS, contact Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."
      ],
      "overdosage": [
        "OVERDOSAGE Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions."
      ],
      "dosage_and_administration": [
        "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."
      ],
      "spl_unclassified_section": [
        "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.",
        "As a neutralizing buffer 3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician.",
        "Rx Only Manufactured by: Belleview Bioscience, LLC Brooksville, FL 34604 Belleview Bioscience Logo"
      ],
      "how_supplied": [
        "HOW SUPPLIED Sodium Citrate and Citric Acid Oral Solu􀆟 on, USP (colorless, grape fl avor) is supplied in the following oral dosage forms: NDC 84447-017-01: 200,000 mL Bulk Drum"
      ],
      "storage_and_handling": [
        "STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - Bulk Drum BULK SHIPMENT CAUTION: FOR REPACKAGING ONLY NDC 84447-017-01 Sodium Citrate - Citric Acid Oral Solution USP 500 mg/334 mg per 5 mL 200,00 mL **Sugar, Alcohol, Gluten and Dye Free** Bulk Label"
      ],
      "set_id": "3245e0e5-5e7f-c3f7-e063-6394a90ac258",
      "id": "395a52e7-d488-26c6-e063-6394a90a8158",
      "effective_time": "20250707",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Sodium Citrate and Citric Acid"
        ],
        "generic_name": [
          "SODIUM CITRATE AND CITRIC ACID MONOHYDRATE"
        ],
        "manufacturer_name": [
          "Belleview Biosciences LLC"
        ],
        "product_ndc": [
          "84447-017"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM CITRATE",
          "ANHYDROUS CITRIC ACID"
        ],
        "rxcui": [
          "543014"
        ],
        "spl_id": [
          "395a52e7-d488-26c6-e063-6394a90a8158"
        ],
        "spl_set_id": [
          "3245e0e5-5e7f-c3f7-e063-6394a90ac258"
        ],
        "package_ndc": [
          "84447-017-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175833",
          "N0000175835",
          "N0000175980",
          "N0000008556",
          "N0000175089"
        ],
        "pharm_class_moa": [
          "Acidifying Activity [MoA]",
          "Calcium Chelating Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Calculi Dissolution Agent [EPC]",
          "Anti-coagulant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Coagulation Factor Activity [PE]"
        ],
        "unii": [
          "1Q73Q2JULR",
          "XF417D3PSL"
        ]
      }
    }
  ]
}