TRIUMEQ- dolutegravir sodium, abacavir sulfate, lamivudine tablet, film coated 
Glaxo Operations UK Ltd

----------

PRINICPAL DISPLAY PANEL

NDC 49702-231-13

Triumeq

(abacavir, dolutegravir, and lamivudine)

600 mg/50 mg/300 mg

TABLETS

Each film-coated tablet contains abacavir sulfate equivalent to 600 mg of abacavir, dolutegravir sodium equivalent to 50 mg of dolutegravir, and 300 mg of lamivudine.

Store in original package at controlled room temperature of 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP). Keep bottle tightly closed; protect from moisture. Do not remove desiccant.

Do not use if printed safety seal under cap is broken or missing.

See prescribing information for dosage information.

Notice to Authorized Dispenser:

Each time TRIUMEQ is dispensed, give the patient a Medication Guide and Warning Card from the carton.

Rx only

30 Tablets

 
10000000147131 Rev. 8/17
Triumeq 30 count carton
TRIUMEQ 
dolutegravir sodium, abacavir sulfate, lamivudine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-053
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOLUTEGRAVIR SODIUM (UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1) DOLUTEGRAVIR50 mg
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS) ABACAVIR600 mg
LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95) LAMIVUDINE300 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize22mm
FlavorImprint Code 572;Tri
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-053-0030 in 1 BOTTLE; Type 0: Not a Combination Product08/22/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA20555108/22/2014
Labeler - Glaxo Operations UK Ltd (424738227)

Revised: 12/2017
 
Glaxo Operations UK Ltd