exeltis usa, inc. - Medication Listings

Benznidazole Tablets contain benznidazole, a nitroimidazole antimicrobial. The chemical name of benznidazole is N-benzyl-2-(2-nitro-1H-imidazol-1-yl) acetamide. The empirical formula is C 12 H 12 N 4 O 3 and the molecular weight is 260.246 g/mol. The structural formula is: Figure 1: Benznidazole Structure Benznidazole is a yellowish, practically crystalline powder that is practically insoluble in water, sparingly soluble in acetone and ethanol, and slightly soluble in methanol. Benznidazole Tablets are white round tablets each containing 12.5 mg or 100 mg of benznidazole, for oral use. The 100 mg white tablets are round and functionally scored twice as a cross on both sides debossed with “E” on one side of each quarter portion. The 12.5 mg white tablets are round and unscored debossed with “E” on one side. The inactive ingredients are as follows: magnesium stearate, NF; microcrystalline cellulose, NF; monohydrate lactose, NF; pre-gelatinized corn starch, NF; and sodium croscarmellose, NF. structure

NUVESSA contains 1.3% metronidazole, USP in a single-dose prefilled disposable applicator. It is intended for intravaginal use. Metronidazole is a nitroimidazole antimicrobial. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. Its structural formula is: The molecular formula is C 6 H 9 N 3 O 3 with a molecular weight of 171.16. NUVESSA is an aqueous gel containing metronidazole at a concentration of 13 mg/g (1.3%). The gel is formulated at pH 4.0. The gel also contains benzyl alcohol, methylparaben, polycarbophil, polyethylene glycol 400, propylene glycol, propylparaben, and purified water. Each applicator contains approximately 65 mg of metronidazole in 5 g of vaginal gel. Chemical Structure

COMPOSITION Each SELECT-OB ® caplet contains: Vitamin A (as retinyl acetate & beta carotene) 510 mcg RAE (1700 IU) Vitamin C (as ascorbic acid) 60 mg Vitamin D (as cholecalciferol) 10 mcg (400 IU) Vitamin E (as dl-alpha tocopheryl acetate) 13.5 mg (30 IU) Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 5 mcg Iron (as polysaccharide iron complex) 29 mg Magnesium (as magnesium oxide) 25 mg Zinc (as zinc oxide) 15 mg Each softgel capsule contains: Docosahexaenoic acid (DHA) (from natural algal oil) 250 mg Other Ingredients in Select-OB ® caplet: Fructose, Stearic Acid, Mono and Diglycerides, Croscarmellose Sodium, Mixed Berry Flavor WONF, Gelatin (Porcine), Silicon Dioxide, Citric Acid, Magnesium Stearate, Modified Food Starch, Hydroxypropylmethyl Cellulose, Malic Acid, Sucrose, Corn Starch, Dicalcium Phosphate, Sodium Ascorbate, Medium Chain Triglycerides, Sorbic Acid, Tocopherol Concentrate, Sodium Benzoate, dl-Alpha-Tocopherol, Butylated Hydroxytoluene (BHT), Tricalcium Phosphate. Coating: Hydroxypropylmethyl Cellulose, Titanium Dioxide, Polydextrose, Hydroxypropyl Cellulose, Triacetin, Polyethylene Glycol, FD&C Blue #1 / Aluminum Lake, FD&C Blue #2 / Aluminum Lake. Contains: Soy Other Ingredients in DHA softgel capsule: Gelatin, Glycerin USP, Water.

SLYND (drospirenone) is for use as an oral contraceptive. It is supplied as clear to a slightly opaque PVC-PVDC/Aluminum blister cards, each holding of 24 white tablets each containing 4 mg of drospirenone, a synthetic progestational compound and 4 green inert tablets. Drospirenone is chemically described as (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11, 12,13,14,15,15a,16-hexadecahydro10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16]cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione). It has a molecular weight of 366.5, a molecular formula of C 24 H 30 O 3 , and the structural formula below: Drospirenone is a white to almost white or slightly yellow crystalline powder. It is a progestin and neutral molecule with slight solubility in water The active tablet is a 5 mm, round, unscored, film-coated, white tablet that contains 4mg of drospirenone as the active ingredient, and microcrystalline cellulose NF, anhydrous lactose NF, colloidal silicon dioxide NF, magnesium stearate NF, polyvinyl alcohol partially hydrolyzed NF, talc NF, titanium dioxide NF, and polyethylene glycol NF as the inactive ingredients. Each tablet is debossed with the letter "E" on one side and the letter "D" on the other side. The inert tablet is a 5 mm, round, unscored, film-coated, green tablet that does not contain drospirenone. Each inert green tablet contains the following inactive ingredients: lactose monohydrate NF, corn starch NF, povidone 30000 NF, colloidal silicon dioxide NF, magnesium stearate NF, hypromellose 2910 NF, titanium dioxide USP, polysorbate 80 NF, triacetin NF, FD&C blue 2 aluminum lake and yellow ferric oxide. Chemical Structure

COMPOSITION Each caplet contains: Vitamin A (as beta carotene) 900 mcg RAE Vitamin C 300 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as d-alpha tocopheryl succinate) 67 mg Thiamin (as thiamine hydrochloride) 20 mg Riboflavin (vitamin B2) 5 mg Niacin (as niacinamide) 25 mg NE Vitamin B6 (as pyridoxine hydrochloride) 25 mg Folate (as folic acid) 1,670 mcg DFE Vitamin B12 (as cyanocobalamin) 50 mcg Biotin 100 mcg Pantothenic Acid (as calcium-D-pantothenate) 15 mg Magnesium (as magnesium oxide) 50 mg Zinc (as zinc oxide) 25 mg Selenium (as sodium selenate) 100 mcg Copper (as cupric sulfate) 1.5 mg Manganese (as manganese sulfate) 1.5 mg Chromium (as chromium chloride) 50 mcg Alpha Lipoic Acid 7.5 mg Lutein 5 mg Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol.

TYBLUME (levonorgestrel and ethinyl estradiol) tablets is an oral contraceptive product. A TYBLUME pack consists of 21 white active tablets and 7 peach-colored inactive tablets. The twenty-one white active tablets each contain 0.1 mg of levonorgestrel, a progestin, and 0.02 mg of ethinyl estradiol, an estrogen. Each tablet also contains the following inactive ingredients: corn starch, crospovidone, lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch. Seven peach-colored inactive tablets, each contains anhydrous lactose, corn starch, crospovidone, D&C yellow No. 10 aluminum lake, FD&C Red No. 40 aluminum lake, magnesium stearate, and povidone. The chemical name for levonorgestrel is [18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-(-)-]. It has the molecular formula of C 21 H 28 O 2 , the molecular weight of 312.5, and the structural formula is provided below: The chemical name for ethinyl estradiol is [19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. It has the molecular formula of C 20 H 24 O 2 , the molecular weight of 296.4, and the structural formula is provided below: Chemical Structure Chemical Structure

COMPOSITION: Each Vitafol ® Fe+ softgel capsule contains: Vitamin A (as beta carotene) 330 mcg RAE Vitamin C (as ascorbic acid) 60 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as dl-alpha tocopheryl acetate) 9 mg Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate 1700 mcg DFE (680 mcg DFE from folic acid & 1020 mcg DFE from l-methylfolate calcium) Vitamin B12 (as cyanocobalamin) 25 mg Iron (as polysaccharide iron complex) 90 mg Iodine (as potassium iodide) 150 mcg Magnesium (as magnesium oxide) 20 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Docosahexaenoic acid (DHA) (from natural algal oil) 200 mg Other Ingredients: Gelatin (Bovine), Soybean Oil, Glycerin, Yellow Beeswax, Sorbitol, Soy Lecithin, Titanium Dioxide (color), FD&C Red #40, FD&C Blue #1 Contains: Soy

COMPOSITION Each Vitafol ® -OB caplet contains: Vitamin A (as beta carotene) 810 mcg RAE Vitamin C (as ascorbic acid) 70 mg Vitamin D (as cholecalciferol) 10 mcg Vitamin E (as dl-alpha tocopheryl acetate) 13.5 mg Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 18 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Calcium (as calcium carbonate) 100 mg Iron (as ferrous fumarate) 65 mg Magnesium (as magnesium oxide) 25 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Each DHA softgel capsule contains: Docosahexaenoic acid (DHA) (from natural algal oil) 250 mg

COMPOSITION: Each Softgel Capsule Contains: VITAMINS AND MINERALS: Vitamin A (as beta carotene) 330 mcg RAE Vitamin C (as ascorbic acid) 30 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as dl-alpha tocopheryl acetate) 9 mg Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Iron (as polysaccharide iron complex) 29 mg Iodine (as potassium iodide) 150 mcg Magnesium (as magnesium oxide) 20 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Docosahexaenoic acid (DHA) (from natural algal oil) 200 mg Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Sunflower Oil, Microcrystalline Cellulose, FD&C Blue #1, Ethyl Vanillin, Mannitol, Titanium Dioxide. Contains: Soy.

COMPOSITION Amount per Capsule: VITAMINS AND MINERALS: Vitamin A (as beta carotene) 330 mcg RAE Vitamin C (as ascorbic acid) 30 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as dl-alpha tocopheryl acetate) 9 mg Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (680 mcg DFE from folic acid & 1020 mcg DFE from l-methylfolate calcium) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Iron (as polysaccharide iron complex) 29 mg Iodine (as potassium iodide) 150 mcg Magnesium (as magnesium oxide) 20 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Docosahexaenoic acid (DHA) (from natural algal oil) 200 mg Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl Vanillin. Titanium Dioxide (color). May contain: Sunflower Oil, Olive Oil. Contains: Soy.