aurovela 24 fe norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
1 INDICATIONS AND USAGE Aurovela 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. Aurovela 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 Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. ( 1 , 8.8 )
aurobindo pharma limited
ROUND BROWN S 57
S 57 ROUND BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Aurovela ® 24 Fe is available in blister packs containing 28 tablets. The Blister Packs are packed in pouches (NDC 65862-934-87) and the pouches are packaged in cartons: Carton of 1 Pouch NDC 65862-934-87 Carton of 3 Pouches NDC 65862-934-88 Carton of 5 Pouches NDC 65862-934-58 Each blister pack (28 tablets) contains in the following order: 24 light yellow to yellow, round, flat-faced, beveled-edge, uncoated (active) tablets debossed with ‘S’ on one side and ‘64’ on other side and each containing 1 mg of norethindrone acetate USP and 20 mcg of ethinyl estradiol USP. 4 brown, mottled, round, flat-faced, beveled-edge (non-hormonal placebo) tablets debossed with ‘S’ on one side and ‘57’ on 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 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light.
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