SORBITOL SOLUTION - Chartwell Governmental & Specialty RX, LLC

Manufacturer
Chartwell Governmental & Specialty RX, LLC
Effective date
2026-04-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:13:21

Label at a glance#

ProductSodium Citrate and Citric Acid
Active ingredientSODIUM CITRATE, CITRIC ACID MONOHYDRATE
Label structure11 sections

Indications and uses

Sodium citrate and citric acid oral solution, 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 contraind...

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 mea...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

A Sugar-Free Systemic Alkalizer

DESCRIPTION

DESCRIPTION SECTION

Sodium Citrate and Citric Acid Oral Solution, USP is a clear stable and cherry flavored systemic alkalizer containing sodium citrate and citric acid in a sugar-free base with cherry flavor. It is a nonparticulate neutralizing buffer.

Sodium Citrate and Citric Acid Oral Solution, USP contains in each teaspoonful (5 mL):

Sodium Citrate Dihydrate, USP 500 mg (0.34 Molar)
Citric Acid Monohydrate, USP 334 mg (0.32 Molar)

Each mL contains 1 mEq sodium ion and is equivalent to 1 mEq bicarbonate (HCO 3).

INACTIVE INGREDIENTS: purified water, saccharin sodium, sodium benzoate, sorbitol solution, and wild cherry flavor.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Sodium citrate and citric acid oral solution, 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 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.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

PRECAUTIONS

PRECAUTIONS SECTION

Sodium citrate and citric acid oral solution 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.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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.

OVERDOSAGE

OVERDOSAGE SECTION

Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

HOW SUPPLIED

HOW SUPPLIED SECTION

Sodium Citrate and Citric Acid Oral Solution, USP (Colorless liquid with cherry flavor) is supplied in the following oral dosage form:

Unit Dose Cup 15 mL:                     NDC 68999-868-51   

20 Unit Dose Cups of 15 mL each : NDC 68999-868-24

Unit Dose Cup 30 mL:                     NDC 68999-869-43     

20 Unit Dose Cups of 30 mL each : NDC 68999-869-24

STORAGE:

Keep tightly closed.  Store at controlled room temperature, 20°-25°C (68°-77°F).  Protect from freezing.

Rx ONLY

Manufactured for:
Chartwell Governmental & Specialty RX, LLC.
Congers, NY 10920

L72916

Rev. 02/2026

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Citrate and Citric Acid Oral Solution, USP - NDC 68999-868-51 - 15 mL Unit-Dose Cup Label

"Image Description""Image Description"

Sodium Citrate and Citric Acid Oral Solution, USP - NDC 68999-869-43 - 30 mL Unit-Dose Cup Label

"Image Description""Image Description"

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
543014citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN2
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD2
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSY2
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSY2
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00368999869436GTIN-14: 00368999869436
GTIN-12: 368999869436
UPC-A: 368999869436
EAN-13: 0368999869436
GTIN storage (14 digits): 00368999869436
sodium-citrate-and-citric-acid-os-30ml-cup-label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-868-24Sodium Citrate and Citric Acid10 in 1 TRAYSOLUTION102
68999-868-24Sodium Citrate and Citric Acid2 in 1 BOXSOLUTION22
68999-868-51Sodium Citrate and Citric Acid15 mL in 1 CUPSOLUTION152
68999-869-24Sodium Citrate and Citric Acid10 in 1 TRAYSOLUTION102
68999-869-24Sodium Citrate and Citric Acid2 in 1 BOXSOLUTION22
68999-869-43Sodium Citrate and Citric Acid30 mL in 1 CUPSOLUTION302

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68999-86868999-868-51, 68999-868-24
68999-86968999-869-43, 68999-869-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
ndc (package): 68999-869-24
ndc (package): 68999-868-51
ndc (package): 68999-869-43
ndc (package): 68999-868-24
ndc (product): 68999-869
ndc (product): 68999-868
ndc11 (package): 68999086924
ndc11 (package): 68999086943
ndc11 (package): 68999086824
ndc11 (package): 68999086851
spl id: 4ee6bc22-bf74-ee36-e063-6394a90a268b
spl set id: 58c24504-47de-487a-ab8d-18add155ea95

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.