OCELLA (Page 9 of 9)

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NDC 54868-5922-0

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OCELLA

(drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg

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

Store at 25°C with excursions permitted between 15–30°C. [See USP Controlled Room Temperature].

To the Dispenser: This unit contains two pieces of information intended for the patient, which are combined in a single booklet. This informational piece is to be provided to the patient with each prescription.

Rx only

OCELLA
drospirenone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5922(NDC:0555-9131)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5922-0 1 BLISTER PACK (BLISTER PACK) in 1 PACKAGE contains a BLISTER PACK
1 1 KIT (KIT) in 1 BLISTER PACK This package is contained within the PACKAGE (54868-5922-0)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
OCELLA
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
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021098 07/31/2008
Part 2 of 2
INERT
inert tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K25
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white) Score no score
Shape ROUND (round) Size 6mm
Flavor Imprint Code ;
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021098 07/31/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021098 07/31/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Schering GmbH und Co. Produktions KG 331485631 manufacture
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 02/2011 Physicians Total Care, Inc.

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