Label: CITRANATAL ASSURE - ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent
- NDC Code(s): 0178-0893-30
- Packager: Mission Pharmacal Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated May 19, 2011
If you are a consumer or patient please visit this version.
- BOXED WARNING(What is this?)
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.Close
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 "0893" on one side and is blank on the other. The essential fatty acid DHA capsule is clear and contains an amber to light/dark orange semi-solid mixture.
Each prenatal capsule contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 125 mg Iron (Carbonyl iron, ferrous gluconate) 35 mg Vitamin D3 (Cholecalciferol) 400 IU Vitamin E (dl-alpha tocopheryl acetate) 30 IU Thiamin (Vitamin B1) 3 mg Riboflavin (Vitamin B2) 3.4 mg Niacinamide (Vitamin B3) 20 mg Vitamin B6 (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) 300 mg Eicosapentaenoic Acid (EPA) Not more than 0.750 mg
DHA is contained in the oil derived from microalgae.
Other ingredients in DHA gelatin capsule: Gelatin, Glycerin USP, Water.Close
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.Close
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.Close
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.Close
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.Close
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.Close
- ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.Close
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.Close
- DOSAGE AND ADMINISTRATION
One tablet and one capsule daily or as directed by a physician.Close
- STORAGE AND HANDLING
Store at controlled room temperature.Close
- HOW SUPPLIED
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0893-30Close
- SPL UNCLASSIFIED SECTION
To report a serious adverse event or obtain product information, call (210) 696-8400.
C02 Rev 010090
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 © 2009 Mission Pharmacal Company.
All rights reserved.
Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247
HEALTHY BRAIN, EYES, HEART
Trademark of Martek Biosciences Corporation
U.S. Patent No. 5,407,957
U.S. Patent No. 5,492,938
*March of Dimes does not endorseClose
specific products or brands.
March of Dimes is a registered trademark
of the March of Dimes Foundation.
- PRINCIPAL DISPLAY PANEL - Six 5-day Blister Pack Carton
Its gentle nature
is its strength
Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule
An Rx prenatal
derived from an
march of dimes®
Mission Pharmacal is a proud
supporter of the March of Dimes.*
Six 5-day Blister Packs
- INGREDIENTS AND APPEARANCE
ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent kit
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0893 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0178-0893-30 6 in 1 CARTON 1 1 in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 5 Part 2 5 Part 1 of 2 PRENATAL VITAMIN
ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper and docusate sodium tablet, coated
Product Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid 120 mg calcium citrate (UNII: MLM29U2X85) (calcium - UNII:SY7Q814VUP) calcium citrate 125 mg Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 35 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU] ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL 30 [iU] Thiamine (UNII: X66NSO3N35) (Thiamine - UNII:X66NSO3N35) Thiamine 3 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 3.4 mg Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 20 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 25 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 150 ug Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 25 mg Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper 2 mg Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium 50 mg Inactive Ingredients Ingredient Name Strength POVIDONE K30 (UNII: U725QWY32X) Croscarmellose Sodium (UNII: M28OL1HH48) Titanium Dioxide (UNII: 15FIX9V2JP) Magnesium Silicate (UNII: 9B9691B2N9) Magnesium Stearate (UNII: 70097M6I30) Shellac (UNII: 46N107B71O) VANILLIN (UNII: CHI530446X) Product Characteristics Color WHITE Score no score Shape OVAL Size 20mm Flavor Imprint Code 0893 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 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 300 mg ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 0.75 mg Inactive Ingredients Ingredient Name Strength Gelatin (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Product Characteristics Color ORANGE (clear, amber to light/dark orange) 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 11/19/2008 Labeler - Mission Pharmacal Company (008117095) Establishment Name Address ID/FEI Business Operations Accucaps Industries Ltd 248441727 MANUFACTURE Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 MANUFACTURE