Femara (Page 11 of 11)

1 6 HOW SUPPLIED/STORAGE AND HANDLING

Packaged in HDPE bottles with a safety screw cap.

2.5 milligram tablets

Bottles of 30 tablets………………………………………………………………………..NDC 54868-4151-0

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

1 7 PATIENT COUNSELING INFORMATION

Information for Patients

Pregnancy: Femara is contraindicated in women of premenopausal endocrine status. The physician needs to discuss the necessity of adequate contraception with women who have the potential to become pregnant including women who are perimenopausal or who recently became postmenopausal, until their postmenopausal status is fully established.

Fatigue and Dizziness: Since fatigue and dizziness have been observed with the use of Femara and somnolence was uncommonly reported, caution is advised when driving or using machinery.

Bone Effects: Consideration should be given to monitoring bone mineral density.

Novartis Pharmaceuticals Corporation
East Hanover, New Jersey, 07936

© Novartis

T2012-10

December 2011

Additional bar code labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PRINCIPAL DISPLAY PANEL

Package Label – 2.5 mg

Rx Only

FEMARA® (letrozole tablets)

2.5 mg per tablet

image of package label
(click image for full-size original)
FEMARA letrozole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4151(NDC:0078-0249)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LETROZOLE (LETROZOLE) LETROZOLE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FERRIC OXIDE RED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (dark yellow) Score no score
Shape ROUND (slightly biconvex with beveled edges) Size 7mm
Flavor Imprint Code FV;CG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4151-0 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020726 02/10/2005
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 01/2012 Physicians Total Care, Inc.

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