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

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®
Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

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 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, 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.

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.

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
Part 2
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: 04/2014
 
Mission Pharmacal Company
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