Jolessa (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

1 Extended-Cycle Tablet Dispensers

91 Tablets Each 91 DAY REGIMEN

NDC 54868-6044-0

image of 0.15/0.3 mg package label
(click image for full-size original)

JolessaTM
(levonorgestrel / ethinyl estradiol tablets) 0.15 mg/0.03 mg

Contains 1 Extended-Cycle Tablet Dispensers, each containing 91 tablets: 84
pink tablets, each containing 0.15 mg levonorgestrel with 0.03 mg ethinyl
estradiol, and 7 white inert tablets.

Rx only

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

Usual Dosage: One tablet daily for 91 consecutive days in the following order: 84 pink tablets followed by 7 white tablets as prescribed.

See enclosed package brochure.

Pharmacist: Dispense patient information with each prescription.

THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. IT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.

JOLESSA levonorgestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6044(NDC:0555-9123)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6044-0 1 BLISTER PACK (BLISTER PACK) in 1 POUCH contains a BLISTER PACK
1 1 KIT (KIT) in 1 BLISTER PACK This package is contained within the POUCH (54868-6044-0)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 84
Part 2 7
Part 1 of 2
JOLESSA levonorgestrel and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
FD&C BLUE NO. 1
FD&C RED NO. 40
HYPROMELLOSE 2208 (15000 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color pink Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;992
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021544 06/24/2009
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYPROMELLOSE 2208 (15000 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;208
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021544 06/24/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021544 06/24/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 01/2011 Physicians Total Care, Inc.

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