MedPath
FDA Product

Potassium Chloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Potassium Chloride

0904-7061

Regulatory Information

0904-7061

ANDA211067

C73584

December 21, 2020

USA

These highlights do not include all the information needed to use POTASSIUM CHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for POTASSIUM CHLORIDE ORAL SOLUTION. POTASSIUM CHLORIDE oral solutionInitial U.S. Approval: 1948

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

191427277

Active Ingredients

Anhydrous Citric Acid

Code: XF417D3PSL

Class Code: IACT

Glycerin

Code: PDC6A3C0OX

Class Code: IACT

Potassium Chloride

Quantity: 20 meq in 15 mL

Code: 660YQ98I10

Class Code: ACTIB

FD&C Yellow NO. 6

Code: H77VEI93A8

Class Code: IACT

Propylene Glycol

Code: 6DC9Q167V3

Class Code: IACT

Propylparaben

Code: Z8IX2SC1OH

Class Code: IACT

Trisodium Citrate Dihydrate

Code: B22547B95K

Class Code: IACT

Methylparaben

Code: A2I8C7HI9T

Class Code: IACT

Sucralose

Code: 96K6UQ3ZD4

Class Code: IACT

Water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

Chloride Ion

Code: Q32ZN48698

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