Carvedilol (Page 7 of 7)

How should I store Carvedilol?

Store carvedilol at less than 86°F (30°C). Keep the tablets dry.
Safely, throw away carvedilol that is out of date or no longer needed.
Keep carvedilol and all medicines out of the reach of children.

General Information about Carvedilol

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use carvedilol for a condition for which it was not prescribed. Do not give carvedilol to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about carvedilol. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about carvedilol that is written for healthcare professionals. You can also find out more about carvedilol by visiting the website www.glenmarkgenerics.com or calling 1 (888)721-7115. This call is free.

What are the ingredients in Carvedilol Tablets?

Active Ingredient: Carvedilol, USP.

Inactive Ingredients: Colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.

Carvedilol tablets USP come in the following strengths: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg.

What is high blood pressure (hypertension)?

Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. High blood pressure makes the heart work harder to pump blood through the body and causes damage to blood vessels. Carvedilol can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure may lower your chance of having a stroke or heart attack.

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:
Glenmark logo

Glenmark Generics Inc., USA Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkgenerics.com

November 2011

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Image of 25mg Label

Image of 25mg Label
(click image for full-size original)

CARVEDILOL carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-512(NDC:68462-163)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL (CARVEDILOL) CARVEDILOL 6.25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code G;41
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35356-512-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:35356-512-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:35356-512-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:35356-512-18 180 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
CARVEDILOL carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-526(NDC:68462-165)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL (CARVEDILOL) CARVEDILOL 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code G41;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35356-526-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:35356-526-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:35356-526-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
Labeler — Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical DBA Quality Care Prducts LLC 831276758 repack (35356-512), repack (35356-526)

Revised: 08/2022 Lake Erie Medical DBA Quality Care Products LLC

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