"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
(norethindrone and ethinyl estradiol) Tablets, Chewable and Ferrous Fumarate Tablets 0.4mg/35mcg
Ferrous fumarate tablets are not USP for dissolution and assay.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
FEMCON® Fe (norethindrone and ethinyl estradiol tablets) provides a regimen for oral contraception derived from 21 white tablets composed of norethindrone and ethinyl estradiol followed by 7 brown ferrous fumarate (placebo) tablets. The chemical name for norethindrone is 17-hydroxy-19-nor-17a-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17a-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural formulas are:
The active white FEMCON Fe (norethindrone and ethinyl estradiol tablets) tablets contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and the following inactive ingredients: dibasic calcium phosphate, lactose, magnesium stearate, maltodextrin, povidone, sodium starch glycolate, spearmint flavor and sucralose.
The brown tablets contain ferrous fumarate, microcrystalline cellulose, magnesium stereate, povidone, sodium starch glycolate, and compressible sugar. The ferrous fumarate tablets do not serve any therapeutic purpose.
What are the possible side effects of birth control pills?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using birth control pills and call your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness, especially on one side of the body;
- sudden and severe headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden cough, wheezing, rapid...
Last reviewed on RxList: 1/29/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Femcon Fe Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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