{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Sodium Citrate and Citric Acid Sodium Citrate and Citric Acid ANHYDROUS CITRIC ACID ANHYDROUS CITRIC ACID SODIUM CITRATE ANHYDROUS CITRIC ACID"
      ],
      "description": [
        "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 non-particulate 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 (HCO 3 ). INACTIVE INGREDIENTS: grape flavoring, purified 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 insuffi ciency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buff ering and neutralizing gastric hydrochloric acid quickly and effectively. Sodium citrate and citric acid oral solution 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 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 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. 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 should be taken diluted in water, followed by additional water, if desired. SHAKE WELL BEFORE USING. 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."
      ],
      "how_supplied": [
        "HOW SUPPLIED Sodium Citrate and Citric Acid Oral Solution, USP (colorless, grape flavor) is supplied in the following oral dosage forms: NDC 81033-017-15: 15 mL unit dose cup NDC 81033-017-50: Case containing 100 unit-dose cups of 15 mL NDC 81033-017-30: 30 mL unit dose cup NDC 81033-017-51: Case containing 100 unit-dose cups of 30 mL"
      ],
      "storage_and_handling": [
        "STORAGE Keep tightly closed. Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Protect from freezing."
      ],
      "spl_unclassified_section": [
        "Rx Only Packaged by: Kesin Pharma Oldsmar, Florida 34677 Revised March 2025 PI Rev. 01 Kesin Pharma Logo"
      ],
      "package_label_principal_display_panel": [
        "NDC 81033-017-50 Sodium Citrate and Citric Acid Oral Solution, USP 1.5g/1g per 15mL Delivers 15mL Case = 100 UD Cups (Do Not Break Case) QTY 1 15 mL UD Cup Case Label",
        "NDC 81033-017-51 Sodium Citrate and Citric Acid Oral Solution, USP 3g/2g per 30mL Delivers 30mL Case = 100 D Cups (Do Not Break Case) QTY 1 30 mL UD Cup Case Label"
      ],
      "set_id": "3140f8fe-0644-7561-e063-6394a90a2c28",
      "id": "334a40cd-5521-39e3-e063-6394a90ab024",
      "effective_time": "20250421",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Sodium Citrate and Citric Acid"
        ],
        "generic_name": [
          "SODIUM CITRATE AND CITRIC ACID"
        ],
        "manufacturer_name": [
          "Kesin Pharma Corporation"
        ],
        "product_ndc": [
          "81033-017"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ANHYDROUS CITRIC ACID",
          "SODIUM CITRATE"
        ],
        "rxcui": [
          "543014"
        ],
        "spl_id": [
          "334a40cd-5521-39e3-e063-6394a90ab024"
        ],
        "spl_set_id": [
          "3140f8fe-0644-7561-e063-6394a90a2c28"
        ],
        "package_ndc": [
          "81033-017-15",
          "81033-017-50",
          "81033-017-30",
          "81033-017-51"
        ],
        "original_packager_product_ndc": [
          "84447-017"
        ],
        "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": [
          "XF417D3PSL",
          "1Q73Q2JULR"
        ]
      }
    }
  ]
}