NDC 0008-1117-34

SAMPLE - NOT FOR SALE

Lybrel™

(90 µg levonorgestrel/20 µg ethinyl estradiol)

TABLETS

This dispenser contains twenty-eight tablets. Each tablet contains 90 µg levonorgestrel and 20 µg ethinyl estradiol.

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

Do not remove ClickCase™ dispenser from sealed plastic tray until use.

Once removed from carton, protect from light by storing ClickCase™ dispenser in the opaque wallet provided.

THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. ORAL CONTRACEPTIVES DO NOT PROTECT AGAINST TRANSMISSION OF HIV (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES (STDs) SUCH AS CHLAMYDIA, GENITAL HERPES, GENITAL WARTS, GONORRHEA, HEPATITIS B, AND SYPHILIS.

Rx only

Wyeth®

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 90 µg/20 µg - SAMPLE CARTON

NDC 0008-1117-34

SAMPLE - NOT FOR SALE

1 ClickCase™ dispenser containing 28 tablets

Lybrel™

(90 µg levonorgestrel/20 µg ethinyl estradiol)

TABLETS

This dispenser contains twenty-eight tablets. Each tablet contains 90 µg levonorgestrel and 20 µg ethinyl estradiol.

To the Dispenser:

Dispense package in its entirety to patient.

Rx only

Wyeth®

LYBREL 
levonorgestrel and ethinyl estradiol   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0008-1117
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL)  LEVONORGESTREL 90 ug
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL)  ETHINYL ESTRADIOL 20 ug
 
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
POLACRILIN POTASSIUM  
HYPROMELLOSE 2910 (6 CPS)  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL 400  
POLYETHYLENE GLYCOL 1450  
FERRIC OXIDE YELLOW  
FERRIC OXIDE RED  
 
Product Characteristics
Color YELLOW (YELLOW)  Score no score 
Shape ROUND (ROUND)  Size 6mm
Flavor  Imprint Code W;1117 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0008-1117-35 10 CARTON In 1 CARTON contains a CARTON (0008-1117-34)
1 0008-1117-34 1 CASE In 1 CARTON This package is contained within the CARTON (0008-1117-35) and contains a CASE
1  28 TABLET In 1 CASE This package is contained within a CARTON (0008-1117-34) and a CARTON (0008-1117-35)
2 0008-1117-30 1 CASE In 1 CARTON contains a CASE
2  28 TABLET In 1 CASE This package is contained within the CARTON (0008-1117-30)
3 0008-1117-20 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK
3  28 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0008-1117-20)
 

Marketing Information
Marketing Category Applicati