Drug Facts
Composition & Profile
Identifiers & Packaging
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 (473 mL) bottle NDC 0121-0595-15: 15 mL unit dose cup. Case contains 100 unit-dose cups of 15 mL (NDC 0121-0595-00), packaged in 10 trays of 10 unit-dose cups each. NDC 0121-1190-30: 30 mL unit dose cup. Case contains 100 unit-dose cups of 30 mL (NDC 0121-1190-00) packaged in 10 trays of 10 unit-dose cups each. .; 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) Pharmaceutical Associates, Inc. Greenville, SC 29605 473 mL Bottle Label; PRINCIPAL DISPLAY PANEL - 15 mL Unit Dose Cup Label Delivers 15 mL NDC 0121-0595-15 S ODIUM C ITRATE and C ITRIC A CID O RAL S OLUTION USP (Sugar Free) 1.5 g/ 1 g per 15 mL SHAKE WELL-DILUTE AS DIRECTED Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 30 mL Unit Dose Cup Label; PRINCIPAL DISPLAY PANEL - 30 mL Unit Dose Cup Label Delivers 30 mL NDC 0121-1190-30 S ODIUM C ITRATE and C ITRIC A CID O RAL S OLUTION USP (Sugar Free) 3 g/ 2 g per 30 mL SHAKE WELL-DILUTE AS DIRECTED Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 30 mL Unit Dose Cup Label
- 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 (473 mL) bottle NDC 0121-0595-15: 15 mL unit dose cup. Case contains 100 unit-dose cups of 15 mL (NDC 0121-0595-00), packaged in 10 trays of 10 unit-dose cups each. NDC 0121-1190-30: 30 mL unit dose cup. Case contains 100 unit-dose cups of 30 mL (NDC 0121-1190-00) packaged in 10 trays of 10 unit-dose cups each. .
- 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) Pharmaceutical Associates, Inc. Greenville, SC 29605 473 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 15 mL Unit Dose Cup Label Delivers 15 mL NDC 0121-0595-15 S ODIUM C ITRATE and C ITRIC A CID O RAL S OLUTION USP (Sugar Free) 1.5 g/ 1 g per 15 mL SHAKE WELL-DILUTE AS DIRECTED Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 30 mL Unit Dose Cup Label
- PRINCIPAL DISPLAY PANEL - 30 mL Unit Dose Cup Label Delivers 30 mL NDC 0121-1190-30 S ODIUM C ITRATE and C ITRIC A CID O RAL S OLUTION USP (Sugar Free) 3 g/ 2 g per 30 mL SHAKE WELL-DILUTE AS DIRECTED Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 30 mL Unit Dose Cup Label
Overview
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). Sodium citrate contains the following inactive ingredients: flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.
Indications & 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.
Dosage & 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.
Warnings & Precautions
No warnings available yet.
Contraindications
Patients on sodium-restricted diets or with severe renal impairment.
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. To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch..
Storage & Handling
STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing.
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