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  • Safely, throw away carvedilol that is out of date or no longer needed.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.

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

March 2011

Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale DriveNipomo, CA 93444

12.5 mg Label
(click image for full-size original)
CARVEDILOL carvedilol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-204(NDC:68462-164)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL (CARVEDILOL) CARVEDILOL 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POLYSORBATE 80
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code G;164
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-204-30 30 TABLET (TABLET) 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 — H.J. Harkins Company, Inc. (147681894)
Registrant — Glenmark Generics Inc., USA (835917282)
Establishment
Name Address ID/FEI Operations
Glenmark Generics Limited 677318665 ANALYSIS, MANUFACTURE

Revised: 12/2011 H.J. Harkins Company, Inc.

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