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Sodium Citrate and Citric Acid 1002 mg/15mL

Sodium Citrate and Citric Acid · SOLUTION · Chartwell Governmental & Specialty RX, LLC

No Recall HistoryCurrently in Shortage
Plain English

Sodium Citrate and Citric Acid is a solution containing sodium citrate and citric acid at 1002 mg/15mL, taken oral. Manufactured by Chartwell Governmental & Specialty RX, LLC.

Key Facts

Brand Name
Sodium Citrate and Citric Acid
Generic Name
Sodium Citrate and Citric Acid
NDC Code (Product)
68999-868
Manufacturer
Chartwell Governmental & Specialty RX, LLC
Strength
1002 mg/15mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Marketing Start
12/08/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

maternal exposure during pregnancy6 reports
pneumonia4 reports
diarrhoea3 reports
drug ineffective3 reports
hypoxia3 reports
vomiting3 reports
alanine aminotransferase increased2 reports
aspartate aminotransferase increased2 reports
blood glucose increased2 reports
chills2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 insuffi ciency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buff ering and neutralizing gastric hydrochloric acid quickly and effectively. Sodium citrate and citric acid oral solution 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

DOSAGE AND ADMINISTRATION Sodium citrate and citric acid oral solution should be taken diluted in water, followed by additional water, if desired. SHAKE WELL BEFORE USING. 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.

Contraindications

CONTRAINDICATIONS Patients on sodium-restricted diets or with severe renal impairment.

Adverse Reactions

ADVERSE REACTIONS Sodium citrate and citric acid oral solution 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 Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Sodium Citrate and Citric Acid used for?

Sodium Citrate and Citric Acid contains Sodium Citrate and Citric Acid. It is a solution taken oral. Consult your doctor for specific uses.

Is Sodium Citrate and Citric Acid a controlled substance?

Sodium Citrate and Citric Acid is not classified as a controlled substance by the DEA.

What is the generic name for Sodium Citrate and Citric Acid?

The generic name for Sodium Citrate and Citric Acid is Sodium Citrate and Citric Acid. There are no other listed brand versions of Sodium Citrate and Citric Acid.

What is the NDC code for Sodium Citrate and Citric Acid 1002 mg/15mL?

The NDC (National Drug Code) for Sodium Citrate and Citric Acid 1002 mg/15mL is 68999-868, listed by Chartwell Governmental & Specialty RX, LLC.

Product NDC

68999-868

Package NDC

68999-868-24

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)