NDC 0121-0595 Sodium Citrate And Citric Acid

Sodium Citrate And Citric Acid Monohydrate

NDC Product Code 0121-0595

NDC 0121-0595-00

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (0121-0595-15)

NDC 0121-0595-16

Package Description: 473 mL in 1 BOTTLE

NDC 0121-0595-30

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Sodium Citrate And Citric Acid with NDC 0121-0595 is a a human prescription drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Sodium Citrate And Citric Acid is sodium citrate and citric acid monohydrate. The product's dosage form is solution and is administered via oral form.

Labeler Name: Pharmaceutical Associates, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sodium Citrate And Citric Acid Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM CITRATE 500 mg/5mL
  • ANHYDROUS CITRIC ACID 334 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmaceutical Associates, Inc.
Labeler Code: 0121
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-01-1969 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sodium Citrate And Citric Acid Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

A Sugar-Free Systemic Alkalizer

Rx ONLYManufactured 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) bottleNDC 0121-0595-15:  15 mL unit dose cupNDC 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 cupNDC 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.

* Please review the disclaimer below.