Sodium Citrate and Citric Acid

Sodium Citrate and Citric Acid is an FDA-registered drug product whose active ingredient is SODIUM CITRATE AND CITRIC ACID MONOHYDRATE. It is labelled by Cardinal Health 107, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 55154-5777, label effective 20260612. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing SODIUM CITRATE AND CITRIC ACID MONOHYDRATE are most often described in connection with: sodium citrate, citric acid, oral solution, usp effective, alkalinizing agent, long-term maintenance, alkaline urine, alleviation chronic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 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 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..

What is Sodium Citrate and Citric Acid used for?
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 …

Who makes Sodium Citrate and Citric Acid?
Cardinal Health 107, LLC is the labeler of record for Sodium Citrate and Citric Acid.

What form does Sodium Citrate and Citric Acid come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sodium Citrate and Citric Acid prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Sodium Citrate and Citric Acid been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.