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 kit
-
Contains inactivated NDC Code(s)
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.
Drug Label Information
Updated May 19, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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 "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.
- INDICATIONS
- CONTRAINDICATIONS
- BOXED WARNING (What is this?)
-
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
- PRECAUTIONS
- ADVERSE REACTIONS
- CAUTION
- DOSAGE AND ADMINISTRATION
- STORAGE AND HANDLING
- HOW SUPPLIED
-
SPL UNCLASSIFIED SECTION
To report a serious adverse event or obtain product information, call (210) 696-8400.
50289
C02 Rev 010090Mission®
PHARMACALDHA capsules manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Prenatal tablets manufactured by:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355www.missionpharmacal.com
Copyright © 2009 Mission Pharmacal Company.
All rights reserved.
Ferr-Ease™
Dual-iron deliveryTrademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247life's DHA™
HEALTHY BRAIN, EYES, HEARTTrademark of Martek Biosciences Corporation
U.S. Patent No. 5,407,957
U.S. Patent No. 5,492,938*March of Dimes does not endorse
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
Rx Only
NDC 0178-0893-30Its gentle nature
is its strengthCitraNatalAssure®
Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule
An Rx prenatal
vitamin and
omega-3 (DHA)
derived from an
all natural
plant sourcemarch of dimes®
Mission Pharmacal is a proud
supporter of the March of Dimes.*CONTAINS
Six 5-day Blister PacksMission®
PHARMACAL -
INGREDIENTS AND APPEARANCE
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 kitProduct 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, coatedProduct 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 capsuleProduct 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