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: 1.5 g/1 g in 15 mL cups packaged as 100 cups (10 x 10) NDC 60687-832-16 3 g/2 g in 30 mL cups packaged as 100 cups (10 x 10) NDC 60687-834-76; Package/Label Display Panel – Cup Lid – 1.5 g/1 g per 15 mL Rx Only NDC 60687- 832 -44 Sodium Citrate and Citric Acid ORAL SOLUTION, USP 1.5 g/1 g per 15 mL Sugar Free Delivers 15 mL SHAKE WELL – DILUTE AS DIRECTED PROTECT FROM FREEZING. See package insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0595C150224 1 g-1.5 g per 15 mL Sodium Citrate and Citric Acid Oral Solution Cup Lid; Package/Label Display Panel – Cup Lid – 3 g/2 g per 30 mL Rx Only NDC 60687- 834 -45 Sodium Citrate and Citric Acid ORAL SOLUTION, USP 3 g/2 g per 30 mL Sugar Free Delivers 30 mL SHAKE WELL – DILUTE AS DIRECTED PROTECT FROM FREEZING. See package insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0595C300224 2 gm/3 gm per 30 mL Sodium Citrate and Citric Acid Oral Solution Cup Lid
- HOW SUPPLIED Sodium Citrate and Citric Acid Oral Solution USP (colorless, grape flavor) is supplied in the following oral dosage forms: 1.5 g/1 g in 15 mL cups packaged as 100 cups (10 x 10) NDC 60687-832-16 3 g/2 g in 30 mL cups packaged as 100 cups (10 x 10) NDC 60687-834-76
- Package/Label Display Panel – Cup Lid – 1.5 g/1 g per 15 mL Rx Only NDC 60687- 832 -44 Sodium Citrate and Citric Acid ORAL SOLUTION, USP 1.5 g/1 g per 15 mL Sugar Free Delivers 15 mL SHAKE WELL – DILUTE AS DIRECTED PROTECT FROM FREEZING. See package insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0595C150224 1 g-1.5 g per 15 mL Sodium Citrate and Citric Acid Oral Solution Cup Lid
- Package/Label Display Panel – Cup Lid – 3 g/2 g per 30 mL Rx Only NDC 60687- 834 -45 Sodium Citrate and Citric Acid ORAL SOLUTION, USP 3 g/2 g per 30 mL Sugar Free Delivers 30 mL SHAKE WELL – DILUTE AS DIRECTED PROTECT FROM FREEZING. See package insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0595C300224 2 gm/3 gm per 30 mL Sodium Citrate and Citric Acid Oral Solution Cup Lid
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 (HCO 3 ). 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: Store at controlled room temperature, 20° to 25°C (68° to 77°F). Protect from freezing. Rx ONLY DO NOT USE IF SEAL IS BROKEN.
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