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 
Mission Pharmacal Company

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.

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CitraNatalAssure®
Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

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 Acid1  mg
Iodine (Potassium iodide)150  mcg
Zinc (Zinc oxide)25  mg
Copper (Cupric oxide)2  mg
Docusate Sodium50  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

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 B12 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.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

DOSAGE AND ADMINISTRATION

One tablet and one capsule daily or as directed by a physician.

Store at controlled room temperature.

NOTICE

Contact with moisture can discolor or erode the tablet.

HOW 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.

50289
C02 Rev 010090

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

www.missionpharmacal.com

Copyright © 2009 Mission Pharmacal Company.

All rights reserved.

Ferr-Ease
Dual-iron delivery

Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247

life's DHA
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 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
0178-0893-30

Its gentle nature
is its strength

CitraNatalAssure®

Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

An Rx prenatal
vitamin and
omega-3 (DHA)
derived from an
all natural
plant source

march of dimes®

Mission Pharmacal is a proud
supporter of the March of Dimes.*

CONTAINS
Six 5-day Blister Packs

Mission®
PHARMACAL

PRINCIPAL DISPLAY PANEL - Six 5-day Blister Pack Carton
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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0893
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0893-306 in 1 CARTON
11 in 1 BLISTER PACK
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 2
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid120 mg
calcium citrate (UNII: MLM29U2X85) (calcium - UNII:SY7Q814VUP) calcium citrate125 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 35 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL30 [iU]
Thiamine (UNII: X66NSO3N35) (Thiamine - UNII:X66NSO3N35) Thiamine3 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin3.4 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine150 ug
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc25 mg
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper2 mg
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeOVALSize20mm
FlavorImprint Code 0893
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/19/2008
Part 2 of 2
DHA 
doconexent and icosapent capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT300 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT0.75 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorORANGE (clear, amber to light/dark orange) Scoreno score
ShapeCAPSULE Size23mm
FlavorImprint Code
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/19/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/19/2008
Labeler - Mission Pharmacal Company (008117095)
Establishment
NameAddressID/FEIBusiness Operations
Accucaps Industries Ltd248441727MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893MANUFACTURE

Revised: 5/2011
Document Id: 5e1b9d10-6c66-4108-9e93-c59d729cd91d
Set id: 40480393-700d-4afd-8309-704ac8689e85
Version: 1
Effective Time: 20110519
 
Mission Pharmacal Company