OVCON 50 (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

OVCON 50 Carton Label
(click image for full-size original)

28 day

OVCON® 50
(Norethindrone and Ethinyl Estradiol Tablets, USP)

3 Blister cards of
28 Tablets Each

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Rx only

Store below 30º C (86º F).

Three PATIENT INSERTS are enclosed
for your use when dispensing
OVCON® 50

Additional copies are available from
Warner Chilcott (US), LLC
100 Enterprise Drive
Rockaway, NJ 07866

See bottom flap for
lot number and expiration date.

Each of the 21 YELLOW tablets contains
norethindrone (1 mg)
and ethinyl estradiol (0.05 mg).
Each of the 7 GREEN tablets is inert.

Dosage: 1 tablet daily as prescribed.
See package insert enclosed for completeprescribing information.

OVCON 50 norethindrone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0585
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0430-0585-14 72 CARTON (CARTON) in 1 CASE contains a CARTON
1 6 CELLO PACK (CELLO PACK) in 1 CARTON This package is contained within the CASE (0430-0585-14) and contains a CELLO PACK
1 1 BLISTER PACK (BLISTER PACK) in 1 CELLO PACK This package is contained within the CARTON and contains a BLISTER PACK
1 1 KIT (KIT) in 1 BLISTER PACK This package is contained within a CELLO PACK and a CARTON and a CASE (0430-0585-14)
2 NDC:0430-0585-95 10 TRAY (TRAY) in 1 CASE contains a TRAY
2 6 CARTON (CARTON) in 1 TRAY This package is contained within the CASE (0430-0585-95) and contains a CARTON
2 1 CELLO PACK (CELLO PACK) in 1 CARTON This package is contained within the TRAY and contains a CELLO PACK
2 1 BLISTER PACK (BLISTER PACK) in 1 CELLO PACK This package is contained within the CARTON and contains a BLISTER PACK
2 1 KIT (KIT) in 1 BLISTER PACK This package is contained within a CELLO PACK and a CARTON and a TRAY and a CASE (0430-0585-95)
3 NDC:0430-0585-45 72 CARTON (CARTON) in 1 CASE contains a CARTON
3 3 CELLO PACK (CELLO PACK) in 1 CARTON This package is contained within the CASE (0430-0585-45) and contains a CELLO PACK
3 1 BLISTER PACK (BLISTER PACK) in 1 CELLO PACK This package is contained within the CARTON and contains a BLISTER PACK
3 1 KIT (KIT) in 1 BLISTER PACK This package is contained within a CELLO PACK and a CARTON and a CASE (0430-0585-45)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
OVCON 50 norethindrone and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.05 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
LACTOSE
MAGNESIUM STEARATE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WC;585
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017576 07/11/2001
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 7mm
Flavor Imprint Code WC;850
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017576 07/11/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017576 07/11/2001
Labeler — Warner Chilcott (US), LLC (957203177)
Establishment
Name Address ID/FEI Operations
Warner Chilcott Company, LLC 152356536 MANUFACTURE

Revised: 04/2009 Warner Chilcott (US), LLC

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