hailey fe 120 norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
INDICATIONS AND USAGE Hailey Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Adapted from RA Hatcher et al, Reference 7. * The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. ** This term represents "typical" couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. *** N/A—Data not available. TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected * Typical ** (No contraception) (85) (85) Oral contraceptives combined progestin only 0.1 0.5 3 N/A *** N/A *** Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 Vaginal Sponge nulliparous parous 9 20 20 40 Implant 0.05 0.05 Injection: depot medroxyprogesterone acetate 0.3 0.3 IUD progesterone T copper T 380A LNg 20 1.5 0.6 0.1 2 0.8 0.1 Condom without spermicides female male 5 3 21 14 Cervical Cap with spermicidal cream or jelly nulliparous parous 9 26 20 40 Periodic abstinence (all methods) 1 to 9 25 Withdrawal 4 19 Female sterilization 0.5 0.5 Male sterilization 0.10 0.15
glenmark pharmaceuticals inc., usa
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HOW SUPPLIED Hailey ® Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP) is available in dispensers each containing 21 white to off-white tablets and 7 brown to dark brown tablets. Each white to off-white round, flat faced beveled edge uncoated tablets debossed with '16' on one side and 'G' on other side contains 1 mg of norethindrone acetate, USP and 20 mcg of ethinyl estradiol, USP. Each brown to dark brown, round, flat faced beveled edge, uncoated tablets debossed with '17' on one side and 'G' on other side tablet contains 75 mg ferrous fumarate, USP. NDC 68462-419-29 Carton of 3 blister of 28 tablets Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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