hailey 24 fe norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
1 INDICATIONS AND USAGE Hailey 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies ( 14 )]. The efficacy of Hailey 24 Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Hailey 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. ( 1 ) The efficacy of Hailey 24 Fe in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 )
glenmark pharmaceuticals inc., usa
ROUND WHITE G 16
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Hailey ® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP) is available in blister dispensers containing 28 tablets: NDC 68462-731-29 Cartons of 3 blisters containing 28 tablets. Each blister (28 tablets) contains in the following order: • 24 white to off-white, round, flat faced beveled edge, uncoated tablets debossed with ‘16’ on one side and ‘G’ 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, uncoated tablets debossed with ‘17’ on one side and ‘G’ on the other side and each containing 75 mg ferrous fumarate, USP. The ferrous fumarate tablets do not serve any therapeutic purpose. 16.2 Storage Conditions • Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. • Protect from light.
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