Letrozole (Page 12 of 12)

16 HOW SUPPLIED/STORAGE AND HANDLING

Letrozole Tablets, USP are available containing 2.5 mg of letrozole, USP.

The 2.5 mg tablets are pink film-coated, round tablets debossed with M on one side of the tablet and L71 on the other side. They are available as follows:

NDC 0378-2071-93
bottles of 30 tablets

NDC 0378-2071-05
bottles of 500 tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

Information for Patients

Pregnancy

Letrozole tablets are 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 letrozole and somnolence was uncommonly reported, caution is advised when driving or using machinery.

Bone Effects

Consideration should be given to monitoring bone mineral density.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

REVISED OCTOBER 2014
LETR:R4

PRINCIPAL DISPLAY PANEL — 2.5 mg

NDC 0378-2071-93

Letrozole
Tablets, USP
2.5 mg

Rx only 30 Tablets

Each film-coated tablet contains:
Letrozole, USP 2.5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Mylan.com

RM2071H2

Letrozole Tablets, USP 2.5 mg Bottle Label
(click image for full-size original)
LETROZOLE letrozole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-2071
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
D&C RED NO. 27
FD&C BLUE NO. 2
FD&C RED NO. 40
HYPROMELLOSES
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6mm
Flavor Imprint Code M;L71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-2071-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078190 04/22/2011
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 10/2014 Mylan Pharmaceuticals Inc.

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