rmation about TEGRETOL. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about TEGRETOL that is written for health professionals .
For more information, go to www.pharma.us.novartis.com or call 1-888-669-6682.
What are the ingredients in TEGRETOL?
Active ingredient: carbamazepine
Inactive ingredients:
TEGRETOL Tablets: colloidal silicon dioxide, D&C Red No. 30 Aluminum Lake (chewable tablets only), FD&C Red No. 40 (200 mg tablets only), flavoring (chewable tablets only), gelatin, glycerin, magnesium stearate, sodium starch glycolate (chewable tablets only), starch, stearic acid, and sucrose (chewable tablets only).
TEGRETOL Suspension: Citric acid, FD&C Yellow No. 6, flavoring, polymer, potassium sorbate, propylene glycol, purified water, sorbitol, sucrose, and xanthan gum.
TEGRETOL-XR Tablets: cellulose compounds, dextrates, iron oxides, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide (200 mg tablets only).
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
© Novartis
T2014-05
January 2014
PRINCIPAL DISPLAY PANEL
DRUG: Tegretol
GENERIC: carbamazepine
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 61786-445-02
COLOR: pink
SHAPE: CAPSULE
SCORE: Two even pieces
SIZE: 14 mm
IMPRINT: Tegretol;27;27
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
CARBAMAZEPINE 200mg in 1
INACTIVE INGREDIENT(S):
GELATIN
GLYCERIN
MAGNESIUM STEARATE
FD&C RED NO. 40
SILICON DIOXIDE
STEARIC ACID
INGREDIENTS AND APPEARANCE
TEGRETOL
carbamazepine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-445(NDC:0078-0509)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (UNII: 33CM23913M) (CARBAMAZEPINE - UNII:33CM23913M) CARBAMAZEPINE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics
Color pink Score 2 pieces
Shape CAPSULE (capsule shaped) Size 14mm
Flavor Imprint Code Tegretol;27;27
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61786-445-02 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 10/19/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016608 10/19/2015
