TRICITRATES
Tricitrates SF Oral Solution
Approved
Approval ID
d9e6b333-852b-4ddc-a3b7-32994201318e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 21, 2018
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
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 Code17856-0677
Product Classification
G
Generic Name
POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2018
FDA Product Classification
INGREDIENTS (9)
POTASSIUM CITRATEActive
Quantity: 550 mg in 5 mL
Code: EE90ONI6FF
Classification: ACTIB
CITRIC ACID MONOHYDRATEActive
Quantity: 334 mg in 5 mL
Code: 2968PHW8QP
Classification: ACTIM
SODIUM CITRATEActive
Quantity: 500 mg in 5 mL
Code: 1Q73Q2JULR
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
Drug Labeling Information
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 8/21/2018
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.