COREG CR- carvedilol phosphate capsule, extended release 
GlaxoSmithKline Inc

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Principal Display Panel

NDC 0007-3370-13

COREG CR®

(carvedilol phosphate)

Extended-release Capsules

10 mg

30 Capsules

ONCE-A-DAY DOSING

Rx only

www.CoregCR.com

Call 1-888-825-5249

Each extended-release capsule contains 10 mg of carvedilol phosphate. Store at 25oC (77oF) [see USP].

Do not accept if membrane seal under cap is missing or broken.

Dosage: See prescribing information for complete dosing information. This extended-release capsule formulation differs in strength from COREG® tablets.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.

GlaxoSmithKline, RTP, NC 27709

Made in Canada

©2016 the GSK group of companies

Rev. 12/16

10000000143784

Coreg CR 10 mg 30 count label

Principal Display Panel

NDC 0007-3371-13

COREG CR®

(carvedilol phosphate)

Extended-release Capsules

20 mg

30 Capsules

ONCE-A-DAY DOSING

Rx only

www.CoregCR.com

Call 1-888-825-5249

Each extended-release capsule contains 20 mg of carvedilol phosphate. Store at 25oC (77oF) [see USP].

Do not accept if membrane seal under cap is missing or broken.

Dosage: See prescribing information for complete dosing information. This extended-release capsule formulation differs in strength from COREG® tablets.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help GlaxoSmithKline, RTP, NC 27709

Made in Canada

©2017 the GSK group of companies

Rev. 1/17

10000000144411

Coreg CR 20 mg 30 count label

Principal Display Panel

NDC 0007-3372-13

COREG CR®

(carvedilol phosphate)

Extended-release Capsules

40 mg

30 Capsules

ONCE-A-DAY DOSING

Rx only

www.CoregCR.com

Call 1-888-825-5249

Each extended-release capsule contains 40 mg of carvedilol phosphate. Store at 25oC (77oF) [see USP].

Do not accept if membrane seal under cap is missing or broken.

Dosage: See prescribing information for complete dosing information. This extended-release capsule formulation differs in strength from COREG® tablets.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.

GlaxoSmithKline, RTP, NC 27709

Made in Canada

©2016 the GSK group of companies

Rev. 12/16

10000000143783

Coreg CR 40 mg 30 count label

Principal Display Panel

NDC 0007-3373-13

COREG CR®

(carvedilol phosphate)

Extended-release Capsules

80 mg

30 Capsules

ONCE-A-DAY DOSING

Rx only

www.CoregCR.com

Call 1-888-825-5249

Each extended-release capsule contains 80 mg of carvedilol phosphate. Store at 25oC (77oF) [see USP].

Do not accept if membrane seal under cap is missing or broken.

Dosage: See prescribing information for complete dosing information. This extended-release capsule formulation differs in strength from COREG® tablets.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.

GlaxoSmithKline, RTP, NC 27709

Made in Canada

©2016 the GSK group of companies

Rev. 12/16

10000000143785

Coreg CR 80 mg 30 count label
COREG  CR
carvedilol phosphate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53873-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARVEDILOL PHOSPHATE (UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL PHOSPHATE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITE, GREENScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code GSK;COREG;CR;10;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-011-0030 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2007
2NDC:53873-011-017 in 1 BOTTLE; Type 0: Not a Combination Product02/09/200701/09/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02201202/09/2007
COREG  CR
carvedilol phosphate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53873-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARVEDILOL PHOSPHATE (UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL PHOSPHATE20 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITE, YELLOWScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code GSK;COREG;CR;20;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-012-0030 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2007
2NDC:53873-012-017 in 1 BOTTLE; Type 0: Not a Combination Product02/06/200711/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02201202/06/2007
COREG  CR
carvedilol phosphate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53873-013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARVEDILOL PHOSPHATE (UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL PHOSPHATE40 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorGREEN, YELLOWScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code GSK;COREG;CR;40;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-013-0030 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02201202/14/2007
COREG  CR
carvedilol phosphate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53873-014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARVEDILOL PHOSPHATE (UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL PHOSPHATE80 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code GSK;COREG;CR;80;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-014-0030 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2007
2NDC:53873-014-017 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02201202/20/2007
Labeler - GlaxoSmithKline Inc (205556368)

Revised: 12/2017
Document Id: 6ba48e5d-78e6-4a43-b946-42ab56178e57
Set id: 3897f80d-6d7c-4f0b-98e4-137a178165e0
Version: 2
Effective Time: 20171204
 
GlaxoSmithKline Inc