Tricitrates SF Oral Solution

Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2024-11-15
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 21:17:25

Label at a glance#

ProductTRICITRATES
Active ingredientPOTASSIUM CITRATE, SODIUM CITRATE, CITRIC ACID MONOHYDRATE
Label structure12 sections

Dosage and administration

Tricitrates SF Oral Solution should be taken diluted in water, followed by additional water, if desired. Palatability is enhanced if chilled before taking. 3 to 6 teaspoonfuls (15 to 30 mL), diluted in water, four times a day, after meals and at bedtime, or as directed by a physician. 1 to 3 teaspoonfuls (5 to 15 mL), diluted in water, four times a day, after meals and at bedtime, or as directed by a physician. 2 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx ONLY

DESCRIPTION

DESCRIPTION SECTION

Tricitrates SF 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.

Tricitrates SF Oral Solution contains in each teaspoonful (5 mL):

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 (HCO 3).

Inactive Ingredients: FD&C Yellow No. 6, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.

ACTIONS

MECHANISM OF ACTION SECTION

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 ADVANTAGES

INDICATIONS & USAGE SECTION

Tricitrates SF 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 dosage. 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

CONTRAINDICATIONS SECTION

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.

PRECAUTIONS AND WARNINGS

WARNINGS SECTION

PRECAUTIONS SECTION

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 preparations 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

ADVERSE REACTIONS SECTION

Tricitrates SF 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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Tricitrates SF Oral Solution should be taken diluted in water, followed by additional water, if desired. Palatability is enhanced if chilled before taking.

Usual Adult Dose

SPL UNCLASSIFIED SECTION

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

Usual Pediatric Dose

SPL UNCLASSIFIED SECTION

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

Usual Dosage Range

SPL UNCLASSIFIED SECTION

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.

OVERDOSAGE

OVERDOSAGE SECTION

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.

HOW SUPPLIED

HOW SUPPLIED SECTION

Tricitrates SF Oral Solution (orange colored, raspberry flavored) is supplied in the following oral dosage form:

NDC 0121-0677-16:    16 fl oz (473 mL) bottles

STORAGE

STORAGE AND HANDLING SECTION

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

SHAKE WELL BEFORE USING.

SPL UNCLASSIFIED SECTION

Manufactured By

Pharmaceutical Associates, Inc.
Greenville, SC 29605

R08/22

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0677-16

Tricitrates SF
Oral Solution

550 mg/500 mg/334 mg 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 (HCO 3).

May not meet USP monograph requirements for
pH.

16 fl oz (473 mL)

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309317citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN6
309317citric acid 66.8 MG/ML / potassium citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD6
309317citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY6
309317Citric Acid 66.8 MG/ML / K+ citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSY6
309317Citric Acid 66.8 MG/ML / Pot citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0677-16TRICITRATES473 mL in 1 BOTTLESOLUTION4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0677TRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]6Current NDC, Legacy NDC, 1 package rows20241116_2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0677-16ML - Milliliter0121-0677dede80bd-4a6a-49f8-8397-6a4f798ef8bf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QP1
POTASSIUM CITRATEACTIVE INGREDIENTEE90ONI6FF1
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULR1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0121-06770121-0677-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
ndc (package): 0121-0677-16
ndc (product): 0121-0677
ndc11 (package): 00121067716
spl id: 3082f36b-0006-4aee-9019-38995d2292fd
spl set id: 2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.