Tricor (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

TRICOR® (fenofibrate tablets) is available in two strengths:

48 mg

Yellow tablets, imprinted with the code identification letters “FI”, available in bottles of 90 (NDC 0074-3173-90).

Yellow tablets, imprinted with the “a” logo and code identification letters “FI”, available in bottles of 90 (NDC 0074-6122-90).

145 mg

White tablets, imprinted with the code identification letters “FO”, available in bottles of 90 (NDC 0074-3189-90).

White tablets, imprinted with the “a” logo and code identification letters “FO”, available in bottles of 90 (NDC 0074-6123-90).

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

[See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Patients should be advised:

  • of the potential benefits and risks of TRICOR.
  • not to use TRICOR if there is a known hypersensitivity to fenofibrate or fenofibric acid.
  • of medications that should not be taken in combination with TRICOR.
  • that if they are taking coumarin anticoagulants, TRICOR may increase their anti-coagulant effect, and increased monitoring may be necessary.
  • to continue to follow an appropriate lipid-modifying diet while taking TRICOR.
  • to take TRICOR once daily, without regard to food, at the prescribed dose, swallowing each tablet whole.
  • to return to their physician’s office for routine monitoring.
  • to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking TRICOR.
  • to inform their physician of symptoms of liver injury (e.g., jaundice, abdominal pain, nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; or any other new symptoms.
  • not to breastfeed during treatment with TRICOR and for 5 days after the final dose.

Manufactured for AbbVie Inc., North Chicago, IL 60064, U.S.A.by Fournier Laboratories Ireland Limited, Anngrove, Carrigtwohill Co. Cork, Ireland.

20067131 June, 2021

NDC 0074–6122–90

TriCor®

Fenofibrate Tablets

48 mg

90 Tablets

Rx only abbvie

NDC 0074–6122–90 
TriCor®
Fenofibrate Tablets 
48 mg 
90 Tablets 
Rx only abbvie
(click image for full-size original)

NDC 0074–6123–90

TriCor®

Fenofibrate Tablets

145 mg

90 Tablets

Rx only abbvie

NDC 0074–6123–90 
TriCor®
Fenofibrate Tablets 
145 mg 
90 Tablets 
Rx only abbvie
(click image for full-size original)

NDC 0074-3173-90

TriCor®

Fenofibrate Tablets

48 mg

90 Tablets

Rx only abbvie

NDC 0074-3173-90 
TriCor®
Fenofibrate Tablets 
48 mg 
90 Tablets 
Rx only abbvie
(click image for full-size original)

NDC 0074-3189-90

TriCor®

Fenofibrate Tablets

145 mg

90 Tablets

Rx only abbvie

NDC 0074-3189-90 
TriCor®
Fenofibrate Tablets 
145 mg 
90 Tablets 
Rx only abbvie
(click image for full-size original)
TRICOR fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-6122
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 48 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
TALC
XANTHAN GUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
DOCUSATE SODIUM
SUCROSE
SODIUM LAURYL SULFATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
LECITHIN, SOYBEAN
HYPROMELLOSE 2910 (3 MPA.S)
POLYVINYL ALCOHOL, UNSPECIFIED
CROSPOVIDONE (120 .MU.M)
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 12mm
Flavor Imprint Code FI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-6122-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-6122-71)
2 NDC:0074-6122-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021656 11/05/2004 06/10/2017
TRICOR fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-6123
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 145 mg
Inactive Ingredients
Ingredient Name Strength
TALC
XANTHAN GUM
DOCUSATE SODIUM
SUCROSE
SODIUM LAURYL SULFATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
LECITHIN, SOYBEAN
HYPROMELLOSE 2910 (3 MPA.S)
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
CROSPOVIDONE (120 .MU.M)
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape OVAL Size 18mm
Flavor Imprint Code FO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-6123-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-6123-71)
2 NDC:0074-6123-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021656 11/05/2004 01/24/2019
TRICOR fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-3173
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 48 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)
DOCUSATE SODIUM
SUCROSE
SODIUM LAURYL SULFATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
XANTHAN GUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
CROSPOVIDONE (120 .MU.M)
POLYVINYL ALCOHOL, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 12mm
Flavor Imprint Code FI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-3173-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021656 02/05/2016
TRICOR fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-3189
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 145 mg
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM
SUCROSE
SODIUM LAURYL SULFATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
XANTHAN GUM
POLYVINYL ALCOHOL, UNSPECIFIED
CROSPOVIDONE (120 .MU.M)
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape OVAL Size 18mm
Flavor Imprint Code FO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-3189-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021656 02/05/2016
Labeler — AbbVie Inc. (078458370)

Revised: 06/2021 AbbVie Inc.

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