SODIUM CITRATE AND CITRIC ACID solution
Sodium Citrate and Citric Acid by
Drug Labeling and Warnings
Sodium Citrate and Citric Acid by is a Prescription medication manufactured, distributed, or labeled by Kesin Pharma Corporation. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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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 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
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 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
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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.
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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
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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. -
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
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
NDC: 81033-017-50
Sodium Citrate and Citric Acid Oral Solution, USP
1.5g/1g per 15mL
Delivers 15mL
2 Cartons x 50 Unit Doce Cups
QTY 2
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PRINCIPAL DISPLAY PANEL
NDC: 81033-017-51
Sodium Citrate and Citric Acid Oral Solution, USP
3g/2g per 30mL
Delivers 30mL
2 Cartons x 50 Unit Dose Cups
QTY 2
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INGREDIENTS AND APPEARANCE
SODIUM CITRATE AND CITRIC ACID
sodium citrate and citric acid solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 81033-017(NDC:84447-017) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 334 mg in 5 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE 500 mg in 5 mL Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 81033-017-50 100 in 1 CASE 04/01/2025 1 NDC: 81033-017-15 15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC: 81033-017-51 100 in 1 CASE 04/01/2025 2 NDC: 81033-017-30 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2025 Labeler - Kesin Pharma Corporation (117447816)
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