Drug Facts
Composition & Profile
Identifiers & Packaging
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; 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
- 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
- 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
Overview
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.
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 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.
Storage & Handling
STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing.
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