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21 Ethinyl Estradiol 0.02 MG Levonorgestrel 0.1 MG Oral Tablet 7 Inert Ingredients 1 MG Oral Tablet Pack

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 III 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. Table III: Percentage of women experiencing an unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States. % of Women Experiencing an Accidental Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method (1) Typical Use 1 (2) Perfect Use 2 (3) (4) Chance 1 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal 6 2 Post Ovulation 1 Withdrawal 19 4 Cap 7 Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm 7 20 6 56 Condom 8 Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUD Progesterone T 2 1.5 81 Copper T380A 0.8 0.6 78 Lng 20 0.1 0.1 81 Depo Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.1 100 Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides.

Mylan Pharmaceuticals Inc.


4 years ago ROUND WHITE 253 21 Ethinyl Estradiol 0.02 MG  Levonorgestrel 0.1 MG Oral Tablet  7 Inert Ingredients 1 MG Oral Tablet  Pack

ROUND WHITE 253

HOW SUPPLIED Levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg are available in a carton of 3 pouches (NDC 0378-7298-53); each pouch contains a blister pack of 28 tablets. The blister pack contains 28 tablets, as follows: 21 white to off-white, round, biconvex tablets debossed with "253" on one side and plain on the other side (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) and 7 green, round, biconvex tablets debossed with "306" on one side and plain on the other side containing inert ingredients. 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.


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