Yasmin (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — Kit Carton Label

CommUnity Care Federally Qualified Centers

YASMIN
28 DAY 1
CYCLE

Date:

Name:
Dr.

TAKE 1 TABLET DAILY AS DIRECTED.

123456

1/1/01

YASMIN #28 NDC 76413-130-28

Batch: 123456
Lot: 123456
Exp: 1/1/01BAYER

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL -- Kit Carton Label
(click image for full-size original)
YASMIN drospirenone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76413-130(NDC:50419-402)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76413-130-28 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
YASMIN drospirenone and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DROSPIRENONE (DROSPIRENONE) DROSPIRENONE 3 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 6000
MAGNESIUM STEARATE
POVIDONE K25
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code
Contains
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021098 05/11/2001
Part 2 of 2
INERT inert tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSES
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code
Contains
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021098 02/13/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021098 05/11/2001
Labeler — Central Texas Community Health Centers (079674019)
Establishment
Name Address ID/FEI Operations
Central Texas Community Health Centers 079674019 REPACK (76413-130), RELABEL (76413-130)

Revised: 01/2016 Central Texas Community Health Centers

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