MedPath

TRICITRATES

Tricitrates SF Oral Solution

Approved
Approval ID

2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 10, 2023

Manufacturers
FDA

PAI Holdings, LLC

DUNS: 044940096

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0121-0677
Product Classification
G
Generic Name
POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2023
FDA Product Classification

INGREDIENTS (9)

POTASSIUM CITRATEActive
Quantity: 550 mg in 5 mL
Code: EE90ONI6FF
Classification: ACTIB
SODIUM CITRATEActive
Quantity: 500 mg in 5 mL
Code: 1Q73Q2JULR
Classification: ACTIB
CITRIC ACID MONOHYDRATEActive
Quantity: 334 mg in 5 mL
Code: 2968PHW8QP
Classification: ACTIM
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/10/2023

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.

Usual Adult Dose

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

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

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.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

TRICITRATES - FDA Drug Approval Details