6 ethinyl estradiol 0.03 MG levonorgestrel 0.05 MG Oral Tablet 10 ethinyl estradiol 0.03 MG levonorgestrel 0.125 MG Oral Tablet 5 ethinyl estradiol 0.04 MG levonorgestrel 0.075 MG Oral Tablet 7 inert ingredients 1 MG Oral Tablet Pac
INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD Method Perfect Use Typical Use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera ® (injectable progestogen) 0.3 0.3 Oral contraceptives 5 Combined 0.1 NA Progestin only 0.5 NA IUD Progesterone 1.5 2.0 Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 14 (female) without spermicide 5 21 Cervical cap Nulliparous women 9 20 Parous women 26 40 Vaginal sponge Nulliparous women 9 20 Parous women 20 40 Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, jellies, and vaginal suppositories) 6 26 Periodic abstinence (all methods) 1 to 9* 25 Withdrawal 4 19 No contraception (planned pregnancy) 85 85 NA-not available *Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition , NY, NY: Ardent Media, Inc., 1998.
Teva Pharmaceuticals USA, Inc.
ROUND GREEN dp 519
dp 519 ROUND GREEN
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HOW SUPPLIED Enpresse ® (
LEVONORGESTREL AND ETHINYL ESTRADIOL tablets USP – triphasic regimen), are available in packages of six cyclic dispensers. Each cycle contains 28 round tablets as follows: six pink, round, film-coated, biconvex tablets debossed with dp on one side and 510 on the other side, each containing 0.050 mg levonorgestrel and 0.030 mg ethinyl estradiol; five white, round, film-coated, biconvex tablets debossed with dp on one side and 511 on the other side, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; ten orange, round, film-coated, biconvex tablets debossed with dp on one side and 512 on the other side, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol and seven light-green, round, inert tablets debossed with dp on one side and 519 on the other side. NDC: 0555-9047-58 References available upon request. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Brands listed are the trademarks of their respective owners. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. E 9/2022
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