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Sodium Citrate and Citric Acid Oral Solution: Package Insert / Prescribing Info

Package insert / product label
Generic name: sodium citrate and citric acid monohydrate
Dosage form: oral solution
Drug class: Minerals and electrolytes

Medically reviewed by Drugs.com. Last updated on Jul 24, 2024.

A Sugar-Free Systemic Alkalizer

Sodium Citrate and Citric Acid Oral Solution 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 (HCO 3).

Sodium citrate contains the following inactive ingredients: flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.

Sodium Citrate and Citric Acid Oral Solution - 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.

Indications and Usage for Sodium Citrate and Citric Acid Oral Solution

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.

Contraindications

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

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.

Adverse Reactions/Side Effects

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.

Overdosage

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

Sodium Citrate and Citric Acid Oral Solution 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.

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 is Sodium Citrate and Citric Acid Oral Solution 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

Storage and Handling

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.

Distributed by:
American Health Packaging
Columbus, OH 43217

R02/24

Package/Label Display Panel – Cup Lid – 1.5 g/1 g per 15 mL

1 g-1.5 g per 15 mL Sodium Citrate and Citric Acid Oral Solution Cup Lid

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

Package/Label Display Panel – Cup Lid – 3 g/2 g per 30 mL

2 gm/3 gm per 30 mL Sodium Citrate and Citric Acid Oral Solution Cup Lid

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

SODIUM CITRATE AND CITRIC ACID
sodium citrate and citric acid monohydrate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60687-832
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE, UNSPECIFIED FORM1500 mg in 15 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1002 mg in 15 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
Product Characteristics
Color Score
ShapeSize
FlavorGRAPEImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60687-832-1610 in 1 CASE07/21/2024
1NDC:60687-832-5010 in 1 TRAY
1NDC:60687-832-4415 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/21/2024
SODIUM CITRATE AND CITRIC ACID
sodium citrate and citric acid monohydrate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60687-834
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE, UNSPECIFIED FORM3000 mg in 30 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID2004 mg in 30 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
Product Characteristics
Color Score
ShapeSize
FlavorGRAPEImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60687-834-7610 in 1 CASE07/21/2024
1NDC:60687-834-5110 in 1 TRAY
1NDC:60687-834-4530 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/21/2024
Labeler - American Health Packaging (929561009)