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 0074–6123–90

TriCor^®

Fenofibrate Tablets

145 mg

90 Tablets

Rx only abbvie

NDC 0074-3173-90

TriCor^®

Fenofibrate Tablets

48 mg

90 Tablets

Rx only abbvie

NDC 0074-3189-90

TriCor^®

Fenofibrate Tablets

145 mg

90 Tablets

Rx only abbvie

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, 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:0074-6122-90 90 TABLET in 1 BOTTLE None 2 NDC:0074-6122-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-6122-71)

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, UNSPECIFIED 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:0074-6123-90 90 TABLET in 1 BOTTLE None 2 NDC:0074-6123-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-6123-71)

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, UNSPECIFIED 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, UNSPECIFIED 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.