NDC Code(s) : 24987-075-01
Packager : Covis Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Kayexalatesodium polystyrene sulfonate POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-075
Route of Administration ORAL, RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM POLYSTYRENE SULFONATE(UNII: 1699G8679Z)
(POLYSTYRENE SULFONIC ACID - UNII:70KO0R01RY) 		POLYSTYRENE SULFONIC ACID4.1 meq in 1 g
Product Characteristics
Color BROWN (cream to light brown) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-075-01453.6 g in 1 JAR Type 0: Not a Combination Product15/07/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011287 07/15/2013 06/30/2018

PRINCIPAL DISPLAY PANEL

NDC 24987-075-01         K-450           Rx only

Kayexalate ®
sodium polystyrene
sulfonate, USP

                                          Read package insert.

Average adult dose: 15 g (approximately 4 level
teaspoons) one to four time daily in water. See
complete prescribing information.

The effect must be carefully controlled by frequent
serum potassium determinations within each 24 hour
period. Sodium content approximately 60 mEq per 15 g.

Suspension should be freshly prepared and not
stored beyond 24 hours. dispense in tight, light-
resistant containers as defined in the official
compendia.

Store at 25°C (77°F); excursions permitted to
15°–30°C (59°–86°F) [see USP Controlled Room
Temperature].

Mfd. for: Covis Pharmaceuticals, Inc., Cary, NC 27511
Origin Canada   © 2013 Covis Pharmaceuticals, Inc.
100111        Rev. 4/13

Jar Label