SODIUM CITRATE AND CITRIC ACID solution

Sodium Citrate and Citric Acid by

Drug Labeling and Warnings

Sodium Citrate and Citric Acid by is a Prescription medication manufactured, distributed, or labeled by Chartwell RX, LLC, Chartwell Pharmaceuticals Carmel, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

A Sugar-Free Systemic Alkalizer

DESCRIPTION

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

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

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

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

PRECAUTIONS

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

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

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.

HOW SUPPLIED

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

473 mL (16 fl oz) bottle                        : NDC: 62135-434-47
Unit Dose Cup 15 mL                           : NDC: 62135-868-51
20 Unit Dose Cups of 15 mL each        : NDC: 62135-868-24
Unit Dose Cup 30 mL                           : NDC: 62135-869-43
20 Unit Dose Cups of 30 mL each        : NDC: 62135-869-24

STORAGE:

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

Rx ONLY

Manufactured for:
Chartwell RX, LLC
Congers, NY 10920

L71144

Rev. 03/2024

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Sodium Citrate and Citric Acid Oral Solution, USP 500 mg/334 mg per 5 mL - NDC: 62135-434-47 - 473 mL Bottle Label

Sodium Citrate and Citric Acid Oral Solution, USP 1500 mg/1002 mg per 15 mL - NDC: 62135-868-51 - 15 mL Unit Dose Label

Sodium Citrate and Citric Acid Oral Solution, USP 3000 mg/2004 mg per 30 mL - NDC: 62135-869-43 - 30 mL Unit Dose Label

INGREDIENTS AND APPEARANCE

SODIUM CITRATE AND CITRIC ACID 
sodium citrate and citric acid solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62135-434
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	SODIUM CITRATE	500 mg  in 5 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	334 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (clear)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62135-434-47	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/08/2022

SODIUM CITRATE AND CITRIC ACID 
sodium citrate and citric acid solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62135-868
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	SODIUM CITRATE	1500 mg  in 15 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1002 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (clear)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62135-868-24	2 in 1 BOX	05/30/2024
1		10 in 1 TRAY
1	NDC: 62135-868-51	15 mL in 1 CUP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/08/2022

SODIUM CITRATE AND CITRIC ACID 
sodium citrate and citric acid solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62135-869
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	SODIUM CITRATE	3000 mg  in 30 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	2004 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (clear)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62135-869-24	2 in 1 BOX	05/30/2024
1		10 in 1 TRAY
1	NDC: 62135-869-43	30 mL in 1 CUP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/08/2022

Labeler - Chartwell RX, LLC (079394054)