7 Ethinyl Estradiol 0.025 MG norgestimate 0.18 MG Oral Tablet 7 Ethinyl Estradiol 0.025 MG norgestimate 0.215 MG Oral Tablet 7 Ethinyl Estradiol 0.025 MG norgestimate 0.25 MG Oral Tablet 7 Inert Ingredients 1 MG Oral Tablet Pack

1 INDICATIONS AND USAGE Norgestimate and ethinyl estradiol tablets are estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception Norgestimate and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )] .

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] completed suicide` `[3] drug ineffective` `[4] drug abuse` `[5] nausea` `[6] fatigue` `[7] off label use` `[8] seizure` `[9] drug interaction` `[10] headache`

3 years ago

ROUND WHITE 234

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg and 0.25 mg/0.025 mg are available in carton of 3 pouches (NDC 0378-7277-53); each pouch contains a blister pack of 28 tablets. Each blister pack contains 28 tablets in the following order: • 7 white to off-white, round, flat-faced, beveled edge tablets debossed with 234 on one side of the tablet and plain on the other side, each containing 0.18 mg norgestimate and 0.025 mg ethinyl estradiol • 7 light yellow, round, flat-faced, beveled edge tablets debossed with 235 on one side of the tablet and plain on the other side, each containing 0.215 mg norgestimate and 0.025 mg ethinyl estradiol • 7 yellow, round, flat-faced, beveled edge tablets debossed with 236 on one side of the tablet and plain on the other side, each containing 0.25 mg norgestimate and 0.025 mg ethinyl estradiol • 7 green, round, flat-faced, beveled edge tablets (non-hormonal placebo) debossed with 295 on one side of the tablet and plain on the other side, each containing inert ingredients Keep this and all medications out of the reach of children. 16.2 Storage Conditions • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] • Protect from light. • Keep out of the reach of children

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