KLOR-CON M (Page 3 of 3)

HOW SUPPLIED

Klor-Con® M10 Extended-release Tablets, contains 750 mg of potassium chloride (equivalent to 10 mEq of potassium) are white, oblong tablets and imprinted “KC M10”. They are supplied as follows:

Bottles of 90 tablets NDC 0245-5317-90
Bottles of 100 tablets NDC 0245-5317-11
Bottles of 1,000 tablets NDC 0245-5317-10
Unit-dose cartons of 100 tablets NDC 0245-5317-01

Klor-Con® M15 Extended-release Tablets, contains 1,125 mg of potassium chloride (equivalent to 15 mEq of potassium) are white, oblong tablets and imprinted “M 15” and scored for flexibility of dosing. They are supplied as follows:

Bottles of 100 tablets NDC 0245-5318-11
Unit-dose cartons of 100 tablets NDC 0245-5318-01

Klor-Con® M20 Extended-release Tablets, contains 1,500 mg of potassium chloride (equivalent to 20 mEq of potassium) are white, oblong tablets and imprinted “KC M20” and scored for flexibility of dosing. They are supplied as follows:

Bottles of 90 tablets NDC 0245-5319-90
Bottles of 100 tablets NDC 0245-5319-11
Bottles of 500 tablets NDC 0245-5319-15
Bottles of 1,000 tablets NDC 0245-5319-10
Unit-dose cartons of 100 tablets NDC 0245-5319-01

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Keep tightly closed.

Manufactured by
UPSHER-SMITH LABORATORIES, LLC
Maple Grove, MN 55369

Klor-Con and Micro-Dispersible Technology are registered trademarks of Upsher-Smith Laboratories, LLC.

This product may be covered by one or more U.S. patent(s). See www.uslpatents.com.

Certain manufacturing operations have been performed by other firms.

Revised 0319

PRINCIPAL DISPLAY PANEL — 10 mEq K Tablet Bottle Label

NDC 0245-5317-11

Klor-Con® M10

Potassium Chloride
Extended-Release
Tablets, USP

MICRO-DISPERSIBLE TECHNOLOGY®

10 mEq K

100 Tablets
Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL -- 10 mEq K Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mEq K Tablet Bottle Label

NDC 0245-5318-11

Klor-Con® M15

Potassium Chloride
Extended-Release Tablets, USP

MICRO-DISPERSIBLE TECHNOLOGY®

15 mEq K

100 Tablets
Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL -- 15 mEq K Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mEq K Tablet Bottle Label

NDC 0245-5319-11

Klor-Con® M20

Potassium Chloride
Extended-Release Tablets, USP

MICRO-DISPERSIBLE TECHNOLOGY®

20 mEq K

100 Tablets
Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL -- 20 mEq K Tablet Bottle Label
(click image for full-size original)
KLOR-CON M
potassium chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-5317
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
potassium chloride (Potassium cation) potassium chloride 750 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
ethylcellulose, unspecified
microcrystalline cellulose
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code KC;M10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0245-5317-01 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0245-5317-89)
1 NDC:0245-5317-89 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0245-5317-01)
2 NDC:0245-5317-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0245-5317-11 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:0245-5317-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074726 01/18/2011
KLOR-CON M
potassium chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-5318
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
potassium chloride (Potassium cation) potassium chloride 1125 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
ethylcellulose, unspecified
microcrystalline cellulose
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 20mm
Flavor Imprint Code M;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0245-5318-01 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0245-5318-89)
1 NDC:0245-5318-89 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0245-5318-01)
2 NDC:0245-5318-11 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074726 01/18/2011
KLOR-CON M
potassium chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-5319
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
potassium chloride (Potassium cation) potassium chloride 1500 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
ethylcellulose, unspecified
microcrystalline cellulose
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 22mm
Flavor Imprint Code KC;M20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0245-5319-01 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0245-5319-89)
1 NDC:0245-5319-89 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0245-5319-01)
2 NDC:0245-5319-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0245-5319-11 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:0245-5319-15 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:0245-5319-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074726 01/18/2011
Labeler — Upsher-Smith Laboratories, LLC (079111820)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories, LLC 079111820 MANUFACTURE (0245-5317), MANUFACTURE (0245-5318), MANUFACTURE (0245-5319), PACK (0245-5317), PACK (0245-5318), PACK (0245-5319), LABEL (0245-5317), LABEL (0245-5318), LABEL (0245-5319)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories, LLC 047251004 ANALYSIS (0245-5317), ANALYSIS (0245-5318), ANALYSIS (0245-5319)

Revised: 12/2020 Upsher-Smith Laboratories, LLC

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