NDC 69367-322 Potassium Citrate, Sodium Citrate, And Citric Acid
Potassium Citrate, Sodium Citrate, And Citric Acid Monohydrate Solution Oral

Product Information

Potassium Citrate, Sodium Citrate, And Citric Acid is a human prescription drug product labeled by Westminster Pharmaceuticals, Llc. The generic name of Potassium Citrate, Sodium Citrate, And Citric Acid is potassium citrate, sodium citrate, and citric acid monohydrate. The product's dosage form is solution and is administered via oral form.

Product Code69367-322
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Potassium Citrate, Sodium Citrate, And Citric Acid
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Potassium Citrate, Sodium Citrate, And Citric Acid Monohydrate
Product Type 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.
Human Prescription Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Westminster Pharmaceuticals, Llc
Labeler Code69367
Marketing Category 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.
UNAPPROVED DRUG OTHER -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-21-2021
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Potassium Citrate, Sodium Citrate, And Citric Acid?


Product Characteristics

Color(s)ORANGE (C48331)
Flavor(s)RASPBERRY (C73413)

Product Packages

NDC 69367-322-16

Package Description: 473 mL in 1 BOTTLE

Price per Unit: $0.03276 per ML

Product Details

What are Potassium Citrate, Sodium Citrate, And Citric Acid Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Potassium Citrate, Sodium Citrate, And Citric Acid Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 309317 - citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG in 5 mL Oral Solution
  • RxCUI: 309317 - citric acid 66.8 MG/ML / potassium citrate 110 MG/ML / sodium citrate 100 MG/ML Oral Solution
  • RxCUI: 309317 - citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG per 5 ML Oral Solution
  • RxCUI: 309317 - Citric Acid 66.8 MG/ML / K+ citrate 110 MG/ML / sodium citrate 100 MG/ML Oral Solution
  • RxCUI: 309317 - Citric Acid 66.8 MG/ML / Pot citrate 110 MG/ML / sodium citrate 100 MG/ML Oral Solution

Potassium Citrate, Sodium Citrate, And Citric Acid Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

* Please review the disclaimer below.

Potassium Citrate, Sodium Citrate, And Citric Acid Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Rx Only

NDC 69367-322-16

Manufactured for:
Westminster Pharmaceuticals LLC.
Nashville, TN 37217
Rev. 04/21


Description



Potassium Citrate, Sodium Citrate and Citric Acid Oral Solution is a stable and pleasant-tasting oral systemic alkalizer containing potassium citrate, sodium citrate, and citric acid in a sugar-free, non alcoholic base.

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

Potassium Citrate Monohydrate550 mg
Sodium Citrate Dihydrate500 mg
Citric Acid Monohydrate334 mg

Each mL contains 1 mEq potassium ion and 1 mEq sodium ion and is equivalent to 2 mEq bicarbonate (HCO3).


Inactive Ingredients



FD&C yellow #6, purified water, raspberry flavor, sodium benzoate, sodium saccharin, sorbital solution.

Potassium Citrate Monohydrate has the chemical name: 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. Its chemical structure is as follows

C6H5K3O7 + H2O                                  M.W. 324.41

Sodium Citrate Dihydrate has the chemical name: 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, trisodium salt, dihydrate. Its chemical structure is as follows.

C6H5Na3O7 + 2H2O                                       M.W. 294.10

Citric Acid Monohydrate has the chemical name: 1,2,3-Propanetricarboxylic acid, 2-hydroxy-,monohydrate. Its chemical structure is as follows.

C6H8O7 + H2O                                     M.W. 210.14

Clinical Pharmacology



Potassium citrate and sodium citrate are absorbed and metabolized to potassium bicarbonate and sodium bicarbonate, thus acting as systemic alkalizers. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of the citrates are excreted in the urine unchanged.


Indications And Usage



Potassium Citrate, Sodium Citrate and Citric Acid Oral Solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders. This product is highly concentrated and when administered after meals and before bedtime, allows one to maintain an alkaline urine 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 recommended dosages. It is highly palatable, pleasant tasting, and tolerable, even when administered for long periods. Potassium citrate and sodium citrate do not neutralize the gastric juice or disturb digestion.


Contraindications



Severe renal impairment with oliguria or azotemia, untreated Addison's disease, or severe myocardial damage. In certain situations, when patients are on a sodium-restricted diet, the use of potassium citrate may be preferable; or, when patients are on a potassium-restricted diet, the use of sodium citrate may be preferable.


Warnings And Precautions



There have been several reports, published and unpublished, concerning nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts. These lesions may occur with enteric-coated potassium tablets alone or when they are used with nonenteric-coated thiazides, or certain other oral diuretics. These small-bowel lesions have caused obstruction, hemorrhage, and perforation. Surgery was frequently required and deaths have occurred. Based on a large survey of physicians and hospitals, both United States and foreign, the incidence of these lesions is low, and a casual relationship in man has not been definitely established. Available information tends to implicate enteric-coated potassium salts, although lesions of this type also occur spontaneously. Therefore, coated potassium-containing formulations should be administered only when indicated, and should be discontinued immediately if abdominal pain, distention, nausea, vomiting, or gastrointestinal bleeding occur.

Do not exceed recommended dosage. Discontinue use if adverse reactions occur. Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of a physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and, preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt perparations and to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy.

Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination 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



Potassium Citrate, 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 hyperkalemia or alkalosis, especially in the presence of hypocalcemia. Potassium intoxication causes listlessness, weakness, mental confusion, and tingling of extremities.


Overdosage



Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions. Overdosage with potassium salts may cause hyperkalemia and alkalosis, especially in the presence of renal disease.


Dosage And Administration



Potassium Citrate, Sodium Citrate and Citric Acid Oral Solution should be administered by diluting with water, followed by additional water, if desired. Palatability is enhanced if chilled before taking.


Usual Adult Dosage



3 to 6 teaspoonfuls (15 to 30 mL), diluted with water, for times a day, after meals and at bedtime, or as directed by a physician.


Usual Pediatric Dosage



1 to 3 teaspoonfuls (5 to 15 mL), diluted with water, four times a day, after meals and at bedtime, or as directed by a physician.


Usual Dosage Range



2 to 3 teaspoonfuls (10 to 15 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 6.5-7.4. 3 to 4 teaspoonfuls (15 to 20 mL), diluted with water taken four times a day, will usually maintain a urinary pH of 7.0-7.6 throughout most of the 24 hours without unpleasant side effects. To check urine pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.

SHAKE WELL BEFORE USING


How Supplied



Potassium Citrate, Sodium Citrate and Citric Acid Oral Solution (orange colored, raspberry flavored) is supplied in the following form:

NDC 69367-322-16 (16 fl oz bottles).


Storage



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

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.


Principal Display Panel - 473 Ml Bottle Label



NDC: 69367-322-16
Rx Only

Potassium Citrate,
Sodium Citrate
and Citric Acid
Oral Solution

550 mg/500 mg/ 334mg per 5 mL

A SUGAR-FREE
SYSTEMIC ALKALIZER

EACH TEASPOONFUL (5 mL) CONTAINS:
POTASSIUM CITRATE MONOHYDRATE
550 mg
SODIUM CITRATE DIHYDRATE
500 mg
CITRIC ACID MONOHYDRATE
334 mg

Each mL contains 1 mEq Potassium Ion and
1 mEq Sodium Ion, and is equivalent to 2
mEq Bicarbonate (HCO3).

May not meet USP monograph
requirement for pH.

16 FL OZ (473 mL)

Westminster
Pharmaceuticals


* Please review the disclaimer below.