AVANDIA 2MG- rosiglitazone maleate tablet, film coated 
AVANDIA 4MG- rosiglitazone maleate tablet, film coated 
AVANDIA 8MG- rosiglitazone maleate tablet, film coated 
GlaxoSmithKline Inc

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PRINCIPAL DISPLAY PANEL

NDC 0173-0861-18

AVANDIA®

ROSIGLITAZONE MALEATE TABLETS

2 mg

60 Tiltab® Tablets

Rx only

Federal Law requires dispensing of AVANDIA® with the Medication Guide provided with this bottle.

Store at 25oC (77oF); excursions 15o – 30oC (59o – 86oF).

Each Tiltab® tablet contains rosiglitazone maleate equivalent to 2 mg rosiglitazone.

Dispense in a tight, light-resistant container.

Dosage: See accompanying prescribing information.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

Rev. 3/13

A114933

Avandia 2mg 60 count label

PRINCIPAL DISPLAY PANEL

NDC 0173-0863-13

AVANDIA®

ROSIGLITAZONE MALEATE TABLETS

4 mg

30 Tiltab® Tablets

Rx only

Federal Law requires dispensing of AVANDIA® with the Medication Guide provided with this bottle.

Store at 25oC (77oF); excursions 15o – 30oC (59o – 86oF).

Each Tiltab® tablet contains rosiglitazone maleate equivalent to 4 mg rosiglitazone.

Dispense in a tight, light-resistant container.

Dosage: See accompanying prescribing information.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

Rev. 3/13

A114934

Avandia 4mg 30 count label

PRINCIPAL DISPLAY PANEL

NDC 0173-0864-13

AVANDIA®

ROSIGLITAZONE MALEATE TABLETS

8 mg

30 Tiltab® Tablets

Rx only

Federal Law requires dispensing of AVANDIA® with the Medication Guide provided with this bottle.

Store at 25oC (77oF); excursions 15o – 30oC (59o – 86oF).

Each Tiltab® tablet contains rosiglitazone maleate equivalent to 8 mg rosiglitazone.

Dispense in a tight, light-resistant container.

Dosage: See accompanying prescribing information.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

Rev. 3/13

A114935

Avandia 8mg 30 count label
AVANDIA  2MG
rosiglitazone maleate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53873-007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIGLITAZONE MALEATE (UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG) ROSIGLITAZONE2 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3000 (UNII: SA1B764746)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeFREEFORM (pentagonal) Size10mm
FlavorImprint Code GSK;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-007-0060 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02107105/25/2011
AVANDIA  4MG
rosiglitazone maleate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53873-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIGLITAZONE MALEATE (UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG) ROSIGLITAZONE4 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3000 (UNII: SA1B764746)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorORANGEScoreno score
ShapeFREEFORM (pentagonal) Size10mm
FlavorImprint Code GSK;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-008-0030 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02107105/25/2011
AVANDIA  8MG
rosiglitazone maleate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53873-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIGLITAZONE MALEATE (UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG) ROSIGLITAZONE8 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3000 (UNII: SA1B764746)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorRED (red-brown) Scoreno score
ShapeFREEFORM (pentagonal) Size12mm
FlavorImprint Code GSK;8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-009-0030 in 1 BOTTLE; Type 0: Not a Combination Product05/25/201109/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02107105/25/201109/30/2016
Labeler - GlaxoSmithKline Inc (205556368)

Revised: 12/2017
 
GlaxoSmithKline Inc