Prescription Drug Information: Microgestin 1/20 (Page 4 of 7)

HOW SUPPLIED

Microgestin 1/20 is available in dispensers (NDC 51862-868-01) each containing 21 pale yellow tablets. Each pale yellow, biconvex, round tablet debossed with “L2” on one side contains 1mg of norethindrone acetate and 20 mcg of ethinyl estradiol.

Microgestin 1/20 Tablets are available in the following configurations:

Carton of 1 NDC 51862-868-02

Carton of 3 NDC 51862-868-03

Carton of 6 NDC 51862-868-06

Store at 20 ˚C ~ 25 ˚C (68 ˚F~77 ˚F) [See USP Controlled Room Temperature].

REFERENCES

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58. Henderson, B.E., S. Preston-Martin, H.A. Edmondson, R.L. Peters, and M.C. Pike: Hepatocellular carcinoma and oral contraceptives. Brit. J. Cancer, 48:437-440, 1983.

59. Neuberger, J., D. Forman, R. Doll, and R. Williams: Oral contraceptives and hepatocellular carcinoma. Brit. Med. J., 292:1355-1357, 1986.

60. Forman, D., T.J. Vincent, and R. Doll: Cancer of the liver and oral contraceptives. Brit. Med. J., 292: 1357-1361, 1986.

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81. Ory, H.W.: Functional ovarian cysts and oral contraceptives: Negative association confirmed surgically. J.A.M.A., 228:68-69, 1974.

82. Ory, H.W., P. Cole, B. Macmahon, and R. Hoover: Oral contraceptives and reduced risk of benign breast disease. N.E.J.M., 294:41-422, 1976.

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85. Miller, D.R., L. Rosenberg, D.W. Kaufman, P. Stolley, M.E. Warshauer, and S. Shapiro: Breast cancer before age 45 and oral contraceptive use: new findings. Am. J. Epidemiol., 129:269-280, 1989.

86. Kay, C.R., and P.C. Hannaford: Breast cancer and the pill: a further report from the Royal College of General Practitioners Oral Contraception Study. Br. J. Cancer, 58:675-680, 1988.

87. Stadel, B.V., S. Lai, J.J. Schlesselman, and P. Murray: Oral contraceptives and premenopausal breast cancer in nulliparous women. Contraception, 38:287-299, 1988.

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89. Romieu, I., W.C. Willett, G.A. Colditz, M.J. Stampfer, B. Rosner, C.H. Hennekens, and F.E. Speizer: Prospective study of oral contraceptive use and risk of breast cancer in women. J. Natl. Cancer Inst., 81:1313-1321, 1989.

The patient labeling for oral contraceptive drug products is set forth below.

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

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