Prescription Drug Information: Tribenzor (Page 7 of 7)

17 PATIENT COUNSELING INFORMATION

Pregnancy: Tell female patients of childbearing age about the consequences of exposure to Tribenzor during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] .

Lactation: Advise nursing women not to breastfeed during treatment with Tribenzor [see Use in Specific Populations (8.2)] .

Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. Tell patients that if syncope occurs, Tribenzor should be discontinued until the physician has been consulted. Tell patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope .

Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.

Acute myopia and secondary angle-closure glaucoma: Advise patients to discontinue Tribenzor and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions (5.9)].

Marketed by Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080

8-TRIBCP1 Iss. 02/2022

PRINCIPAL DISPLAY PANEL

NDC 0713-0874-30

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

20 mg/5 mg*/12.5 mg

30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0713-0875-30

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/5 mg*/12.5 mg

30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0713-0876-30

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/5 mg*/25 mg

30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0713-0877-30

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/10 mg*/12.5 mg

30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0713-0878-30

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/10 mg*/25 mg

30 Tablets

TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0874 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SILICON DIOXIDE

Product Characteristics Color orange Score no score Shape ROUND Size 8mm Flavor Imprint Code C51 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0713-0874-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA200175 06/15/2022

TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0875 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SILICON DIOXIDE

Product Characteristics Color yellow Score no score Shape ROUND Size 10mm Flavor Imprint Code C53 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0713-0875-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA200175 06/15/2022

TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0876 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SILICON DIOXIDE

Product Characteristics Color yellow Score no score Shape OVAL Size 15mm Flavor Imprint Code C54 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0713-0876-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA200175 06/15/2022

TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0877 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SILICON DIOXIDE

Product Characteristics Color red Score no score Shape ROUND Size 10mm Flavor Imprint Code C55 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0713-0877-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA200175 06/15/2022

TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0878 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SILICON DIOXIDE

Product Characteristics Color red Score no score Shape OVAL Size 15mm Flavor Imprint Code C57 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0713-0878-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA200175 06/15/2022

Labeler — Cosette Pharmaceuticals, Inc. (116918230)

Revised: 06/2022 Cosette Pharmaceuticals, Inc.