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 0713-0874-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 20 mg/5 mg*/12.5 mg 30 Tablets Rx only
(click image for full-size original)

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 0713-0875-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/5 mg*/12.5 mg 30 Tablets Rx only
(click image for full-size original)

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 0713-0876-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/5 mg*/25 mg 30 Tablets Rx only
(click image for full-size original)

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 0713-0877-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/10 mg*/12.5 mg 30 Tablets Rx only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0713-0878-30

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/10 mg*/25 mg

30 Tablets

PRINCIPAL DISPLAY PANEL NDC 0713-0878-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/10 mg*/25 mg 30 Tablets Rx only
(click image for full-size original)

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.

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.