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supposed to CitraNatal Assure Generic Name: ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent Dosage Form: capsule/tablet Overview Side Effects Dosage Professional Interactions More User Reviews Pricing & Coupons Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. CitraNatal Assure Description CitraNatal Assure is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease , a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, coated, oval multivitamin/mineral tablet. The tablet is debossed "0891" on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture. Each prenatal capsule contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 124 mg Iron (Carbonyl iron, ferrous gluconate) 35 mg Vitamin D 3 (Cholecalciferol) 400 IU Vitamin E (dl-alpha tocopheryl acetate) 30 IU Thiamin (Vitamin B 1 ) 3 mg Riboflavin (Vitamin B 2 ) 3.4 mg Niacinamide (Vitamin B 3 ) 20 mg Vitamin B 6 (Pyridoxine HCl) 25 mg Folic Acid 1 mg Iodine (Potassium iodide) 150 mcg Zinc (Zinc oxide) 25 mg Copper (Cupric oxide) 2 mg Docusate Sodium 50 mg Each DHA gelatin capsule contains: Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil) 300 mg Eicosapentaenoic Acid (EPA) Not more than 0.750 mg Other ingredients in DHA gelatin capsule: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate. Slideshow Breastfeeding and OTC Medication: Safety Tips That You Need To Know INDICATIONS CitraNatal Assure is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. Contraindications This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. Warning Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis. Warning Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Precautions Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Adverse Reactions Allergic sensitization has been reported following both oral and parenteral administration of folic acid. CitraNatal Assure Dosage and Administration One tablet and one capsule daily or as directed by a physician. STORAGE Store at 20 25 C (68 77 F) NOTICE Contact with moisture can discolor or erode the tablet. How is CitraNatal Assure Supplied Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0893-30 To report a serious adverse event or obtain product information, call (210) 696-8400. 51062 C01 Rev 010130 Mission PHARMACAL DHA capsules manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Prenatal tablets manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Copyright 2013 Mission Pharmacal Company. All rights reserved. www.missionpharmacal.com Ferr-Ease Dual-iron delivery Trademark of Mission Pharmacal Company U.S. Patent No. 6,521,247 life's DHA life sDHA is a trademark of DSM. U.S. Patent No. 7,579,174 U.S. Patent No. 7,732,170 U.S. Patent No. 5,518,918 *March of Dimes does not endorse specific products or brands. March of Dimes is a registered trademark of the March of Dimes Foundation. CitraNatal Assure Sample Blister Pack NDC 0178 0891 10 5-Day Sample Pack Carton 6-Count Sample Pack Display CitraNatal Assure Retail Blister Pack NDC 0178 0891 30 Retail Carton CitraNatal Assure ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0178-0891 Packaging # Item Code Package Description 1 NDC:0178-0891-10 5 BLISTER PACK in 1 CARTON 1 1 KIT in 1 BLISTER PACK 2 NDC:0178-0891-30 30 BLISTER PACK in 1 CARTON 2 1 KIT in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 Part 1 of 2 PRENATAL VITAMIN ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper and docusate sodium tablet, coated Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ascorbic acid (ascorbic acid) ascorbic acid 120 mg Iron (Iron ) Iron 35 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU] ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 [iU] Riboflavin (Riboflavin) Riboflavin 3.4 mg Niacinamide (Niacinamide) Niacinamide 20 mg Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg Folic Acid (Folic Acid) Folic Acid 1 mg Iodine (Iodine) Iodine 150 ug Zinc (Zinc) Zinc 25 mg Copper (Copper) Copper 2 mg Docusate Sodium (Docusate) Docusate Sodium 50 mg THIAMINE (THIAMINE ION) THIAMINE 3 mg CALCIUM CITRATE (CALCIUM CATION) CALCIUM CITRATE ANHYDROUS 124 mg Inactive Ingredients Ingredient Name Strength POVIDONE K30 Croscarmellose Sodium Titanium Dioxide Magnesium Silicate Magnesium Stearate Shellac VANILLIN Product Characteristics Color WHITE Score no score Shape OVAL Size 20mm Flavor Imprint Code 0891 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 11/19/2008 Part 2 of 2 DHA doconexent and icosapent capsule Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg ICOSAPENT (ICOSAPENT) ICOSAPENT 0.75 mg Inactive Ingredients Ingredient Name Strength GELATIN SUNFLOWER OIL GLYCERIN LECITHIN, SUNFLOWER ROSEMARY TOCOPHEROL ASCORBYL PALMITATE Product Characteristics Color ORANGE (caramel color) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 11/19/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 04/30/2014 Labeler - Mission Pharmacal Company (008117095) Registrant - Mission Pharmacal Company (927726893) Establishment Name Address ID/FEI Operations Accucaps Industries Limited 248441727 MANUFACTURE(0178-0891) Establishment Name Address ID/FEI Operations Mission Pharmacal Company 927726893 MANUFACTURE(0178-0891) Revised: 10/2016 Mission Pharmacal Company Next Interactions Print this page Add to My Med List More about CitraNatal Assure (multivitamin, prenatal) Side Effects Dosage Information Drug Interactions Pricing & Coupons 2 Reviews Add your own review/rating Drug class: iron products Consumer resources CitraNatal Assure Professional resources Other brands: Prenatal Plus , PreNexa , Prenatal 19 , Docosavit , ... +74 more Related treatment guides Vitamin/Mineral Supplementation during Pregnancy/Lactation} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Iron products Vitamin and mineral combinations Related Drugs iron products ferrous sulfate , Feosol Original , Iron-150 , Dialyvite vitamin and mineral combinations multivitamin , Citracal + D Vitamin / Mineral Supplementation during Pregnancy / Lactation ferrous sulfate , Feosol Original , Prenatal Multivitamins , Fergon , Ferrousal , FeroSul , Prenatal Plus , Slow Fe , Hemocyte , PreNexa , Prenatal 19 , Ferrocite , Stuart Prenatal with Beta Carotene , OB Complete , Docosavit , Prenatal H , Ferate , More... CitraNatal Assure Rating 2 User Reviews 9.5 /10 2 User Reviews 9.5 Rate it!} } vary size-wise


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