FEMCON Fe (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

FEMCON Fe Label
(click image for full-size original)

FEMCON® Fe
(norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets) 0.4 mg/35 mcg
chewable

Five PATIENT INSERTS are enclosed for your use when dispensing FEMCON® Fe.

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 WHITE tablets contains
norethindrone (0.4 mg)
and ethinyl estradiol (35 mcg).
Each BROWN tablets contains
ferrous fumarate (75 mg).

Dosage: 1 tablet daily as prescribed.
See Package Insert enclosed for complete
Prescribing Information.

5 Blister Cards of
28 Tablets Each
Ferrous Fumarate
tablets are not USP
for dissolution and assay.

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

FEMCON FE norethindrone and ethinyl estradiol, and ferrous fumarate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6161(NDC:0430-0482)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6161-0 1 BLISTER PACK (BLISTER PACK) in 1 CELLO PACK contains a BLISTER PACK
1 1 KIT (KIT) in 1 BLISTER PACK This package is contained within the CELLO PACK (54868-6161-0)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
FEMCON FE norethindrone and ethinyl estradiol tablet, chewable
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 0.4 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
LACTOSE
MAGNESIUM STEARATE
MALTODEXTRIN
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SPEARMINT
SUCRALOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WC;581
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021490 09/21/2010
Part 2 of 2
INERT ferrous fumarate tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FERROUS FUMARATE 75 mg
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color brown Score no score
Shape ROUND Size 6mm
Flavor Imprint Code PD;622
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021490 09/21/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021490 09/21/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 04/2009 Physicians Total Care, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.