Sodium Citrate And Citric Acid Solution
FDA Label NDC 0121-0595

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmaceutical Associates, Inc. for the product Sodium Citrate And Citric Acid (NDC 0121-0595). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, clinical pharmacology, indications and usage, contraindications, precautions, adverse reactions, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Description

→ Clinical Pharmacology

→ Indications And Usage

→ Contraindications

→ Precautions

→ Adverse Reactions

→ Overdosage

→ Dosage And Administration

→ Usual Adult Dose

→ Usual Pediatric Dose

→ As A Neutralizing Buffer

→ How Supplied

→ Storage:

→ Principal Display Panel - 473 Ml Bottle Label

→ Principal Display Panel - 30 Ml Unit Dose Cup Label

→ Principal Display Panel - 15 Ml Unit Dose Cup Label

Other

A Sugar-Free Systemic Alkalizer

Rx ONLY

Manufactured By:
Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R06/16

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 (HCO3).

INACTIVE INGREDIENTS: Flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol 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

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

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.

Overdosage

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

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.

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, grape flavor) is supplied in the following oral dosage forms:

NDC 0121-0595-16: 16 fl oz (473 mL) bottle

NDC 0121-0595-15: 15 mL unit dose cup

NDC 0121-0595-00: Case contains 100 unit dose cups of 15 mL (0121-0595-15) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1190-30: 30 mL unit dose cup

NDC 0121-1190-00: Case contains 100 unit dose cups of 30 mL (0121-1190-30) packaged in 10 trays of 10 unit dose cups each.

Storage:

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

Principal Display Panel - 473 Ml Bottle Label

NDC 0121-0595-16
NSN 6505-01-097-4766

Sodium Citrate
and Citric Acid
Oral Solution USP

500 mg/334 mg per 5 mL

A SUGAR-FREE SYSTEMIC ALKALIZER

Each teaspoonful (5 mL) contains:
Sodium Citrate Dihydrate..........500 mg
Citric Acid Monohydrate............334 mg
Each mL provides 1 mEq Sodium Ion and is
equivalent to 1 mEq Bicarbonate (HCO3).

Rx ONLY

16 fl oz (473 mL)

pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

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.

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.

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

Dispense in a tight, light-resistant
container with a child-resistant closure.

INDICATIONS AND USAGE: Sodium
Citrate and Citric Acid Oral Solution
USP is a stable systemic alkalizer in
a palatable sugar-free base. It is
useful in the management of
metabolic acidosis especially when
the administration of potassium salts
is undesirable or contraindicated.

SEE ACCOMPANYING LITERATURE.