Official product label reference
Sodium Citrate and Citric Acid — Pharmaceutical Associates, Inc.
This page contains 11 source sections for SODIUM CITRATE AND CITRIC ACID MONOHYDRATE, oral route. Label set 63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5, version 10.
Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label
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Uses described in the label
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 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 and administration — label text
DOSAGE AND 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.
Contraindications
CONTRAINDICATIONS Patients on sodium-restricted diets or with severe renal impairment.
Adverse reactions
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..
Unclassified section
A Sugar-Free Systemic Alkalizer
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.
Rx ONLY MANUFACTURED BY: Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R03/22
Product 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 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.
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.
Precautions
PRECAUTIONS Sodium Citrate and Citric Acid Oral Solution USP 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.
Overdose information
OVERDOSAGE Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions.
Supply and 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. .
Storage and handling
STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing.
Official sources and product identifiers
- DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
- openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
Substances listed: SODIUM CITRATE, ANHYDROUS CITRIC ACID
RxNorm identifiers: 543014
Package NDC codes
0121-0595-16, 0121-0595-15, 0121-0595-00, 0121-0595-30, 0121-1190-30, 0121-1190-00
Further research and background
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Coverage and corrections
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.
Source retrieved 2026-10-02. Read the source policy.