charlotte 24fe norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
1 INDICATIONS AND USAGE Charlotte 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies ( 14 )] . The efficacy of Charlotte 24 Fe in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. • Charlotte 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy ( 1 ) • The efficacy in females of reproductive potential with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 )
glenmark pharmaceuticals inc., usa
ROUND WHITE Y 21
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Charlotte 24 Fe is available in blisters (dispensers) containing 28 tablets: NDC 68462-852-29 Cartons of 3 blisters (dispensers) Each blister contains 28 tablets in the following order: • 24 white to off-white, round, flat faced beveled edge, (active) chewable uncoated tablets debossed with “21” on one side and “Y” on the other side and each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. • 4 brown to dark brown, round, flat faced beveled edge, (non-hormonal placebo) uncoated tablets debossed with “18” on one side and “G” on the other side and each containing 75 mg ferrous fumarate, USP. The ferrous fumarate tablets, USP do not serve any therapeutic purpose. 16.2 Storage Conditions Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children.
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