Estados Unidos - inglês - NLM (National Library of Medicine)

allegis pharmaceuticals, llc - .beta.-carotene (unii: 01yae03m7j) (.beta.-carotene - unii:01yae03m7j), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol acetate, dl- (unii: wr1wpi7ew8) (.alpha.-tocopherol, dl- - unii:7qwa1rio01), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8r - .beta.-carotene 2100 [iu] - active fe™ is an oral prescription multi-vitamin/multi-mineral dietary supplement for the use in improving the nutritional status of patients with iron deficiency. 1 active fe™ is contraindicated in patients with a known hypersensitivity to any of the components of this product. hemolytic anemia, hemochromatosis and hemosiderosis are contraindications to iron therapy.

Estados Unidos - inglês - NLM (National Library of Medicine)

gm pharmaceuticals, inc. - .beta.-carotene (unii: 01yae03m7j) (.beta.-carotene - unii:01yae03m7j), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol acetate, dl- (unii: wr1wpi7ew8) (.alpha.-tocopherol, dl- - unii:7qwa1rio01), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8r - .beta.-carotene 2100 [iu] - active fe™ is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.1 active fe™ is contraindicated in patients with a known hypersensitivity to any of the components of this product. hemolytic anemia, hemochromatosis and hemosiderosis are contraindications to iron therapy.

Estados Unidos - inglês - NLM (National Library of Medicine)

carwin pharmaceutical associates, llc - vitamin a acetate (unii: 3le3d9d6oy) (vitamin a - unii:81g40h8b0t), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol, dl- (unii: 7qwa1rio01) (.alpha.-tocopherol, dl- - unii:7qwa1rio01), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), pyridox - vitamin a 2500 [iu] - quflora™ fe chewable tablets multivitamin with iron and fluoride 0.25mg is a prescription dietary fluoride supplement providing essential vitamins and minerals. quflora™ fe chewable tablets multivitamin with iron and fluoride 0.25 mg should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.

Estados Unidos - inglês - NLM (National Library of Medicine)

carwin pharmaceutical associates, llc - vitamin a palmitate (unii: 1d1k0n0vvc) (vitamin a - unii:81g40h8b0t, retinol - unii:g2sh0xkk91), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol acetate, d- (unii: a7e6112e4n) (.alpha.-tocopherol, d- - unii:n9pr3490h9), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niac - vitamin a 1500 [iu] in 1 ml - quflora® fe pediatric liquid drops is a prescription dietary supplement providing essential vitamins, iron and fluoride. do not use in areas where drinking water exceeds 0.6 ppm f. do not administer to pediatric patients less than 6 months old.

Estados Unidos - inglês - NLM (National Library of Medicine)

aurobindo pharma limited - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.4 mg - nexesta fe is indicated for use by females of reproductive potential to prevent pregnancy. nexesta fe is contraindicated in females who are known to have or develop the following conditions:  • a high risk of arterial or venous thrombotic diseases. examples include women who are known to:       o smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)]       o have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)]       o have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)]       o have cerebrovascular disease [see warnings and precautions (5.1)]       o have coronary artery disease [see warnings and precautions (5.1)]       o have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)]       o have uncontrolled hypertension [see warnings and precaution

Estados Unidos - inglês - NLM (National Library of Medicine)

allergan, inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.8 mg - generess fe is indicated for use by women to prevent pregnancy. the efficacy of generess fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. generess fe is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to:  - smoke, if over age 35 [see boxed warning, and warnings and precautions ( 5.1 )] - have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions ( 5.1 )] - have cerebrovascular disease [see warnings and precautions ( 5.1 )] - have coronary artery disease [see warnings and precautions ( 5.1 )] - have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions ( 5.1 )] - have inherited or acquired hypercoagulopathies [see warnings and precautions ( 5.1 )] - have

Estados Unidos - inglês - NLM (National Library of Medicine)

actavis pharma, inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.8 mg - layolis fe is indicated for use by women to prevent pregnancy. the efficacy of layolis fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. layolis fe is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to:  - smoke, if over age 35 [see boxed warning , and warnings and precautions ( 5.1 )] - have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions ( 5.1 )] - have cerebrovascular disease [see warnings and precautions ( 5.1 )] - have coronary artery disease [see warnings and precautions ( 5.1 )] - have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions ( 5.1 )] - have inherited or acquired hypercoagulopathies [see warnings and precautions ( 5.1 )] - have uncontrolled hypertension [see warnings and precautions ( 5.5 )] - have diabetes with vascular disease [see warnings and precautions ( 5.7 )] - have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions ( 5.8 )]​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions ( 5.2 )] - liver tumors, benign or malignant, or liver disease [see warnings and precautions ( 5.3 ), use in specific populations ( 8.7 ), and clinical pharmacology ( 12.3 )] - undiagnosed abnormal uterine bleeding [see warnings and precautions ( 5.9 )] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see  warnings and precautions ( 5.4 )] risk summary there is no use for contraception in pregnancy; therefore, generess fe should be discontinued during pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to cocs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. risk summary contraceptive hormones and/or metabolites are present in human milk. cocs can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding [see dosage and administration (2.2)]. the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for generess fe and any potential adverse effects on the breast-fed child from generess fe or from the underlying maternal condition. safety and efficacy of layolis fe have been established in women of reproductive age. efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated.    layolis fe has not been studied in postmenopausal women and is not indicated in this population.    the pharmacokinetics of layolis fe have not been studied in subjects with renal impairment. no studies have been conducted to evaluate the effect of hepatic disease on the disposition of layolis fe. however, steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal [see contraindications ( 4 ), and warnings and precautions ( 5.3 )]. the safety and efficacy of layolis fe in women with a bmi > 35 kg/m2 have not been evaluated.   

Estados Unidos - inglês - NLM (National Library of Medicine)

actavis pharma, inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.8 mg - generess fe is indicated for use by women to prevent pregnancy. the efficacy of generess fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. do not prescribe generess fe to women who are known to have the following: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to:  - smoke, if over age 35 [see boxed warning , and warnings and precautions ( 5.1 )] - have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions ( 5.1 )] - have cerebrovascular disease [see warnings and precautions ( 5.1 )] - have coronary artery disease [see warnings and precautions ( 5.1 )] - have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions ( 5.1 )] - have inherited or acquired hypercoagulopathies [see warnings and precautions ( 5.1 )] - have uncontrolled hypertension [

Estados Unidos - inglês - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.8 mg - kaitlib™ fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy. the efficacy of kaitlib fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. do not prescribe kaitlib fe to women who are known to have the following: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to:     o    smoke, if over age 35 [see  boxed  warning , and  warnings  and  precautions  (5.1.)]     o     have deep vein thrombosis or pulmonary embolism, now or in the past [see  warnings  and  precautions  (5.1)]     o    have cerebrovascular disease [see  warnings  and  precautions  (5.1)]     o    have coronary artery disease [see  warnings  and  precautions  (5.1)]     o    have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see  warnings  and  precautions  (5.1)]

Estados Unidos - inglês - NLM (National Library of Medicine)

lupin limited - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.8 mg - kaitlib™ fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy. the efficacy of kaitlib fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. do not prescribe kaitlib fe to women who are known to have the following: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to:     o    smoke, if over age 35 [see  boxed  warning , and  warnings  and  precautions  (5.1.)]     o     have deep vein thrombosis or pulmonary embolism, now or in the past [see  warnings  and  precautions  (5.1)]     o    have cerebrovascular disease [see  warnings  and  precautions  (5.1)]     o    have coronary artery disease [see  warnings  and  precautions  (5.1)]     o    have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see  warnings  and  precautions  (5.1)]