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 
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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CitraNatal Assure ®















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 "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)124mg
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 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, 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 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.

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.

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.

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30

CitraNatal Assure Sample Blister Pack
NDC 0178–0891–10

CitraNatal Assure Sample Blister

5-Day Sample Pack Carton

5-Day Sample Carton

6-Count Sample Pack Display

Sample Display

CitraNatal Assure Retail Blister Pack
NDC 0178–0891–30

Retail Blister

Retail Carton

citra-natal-assure-carton-0178-0891-30
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0891
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0891-105 in 1 CARTON04/30/2014
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0178-0891-3030 in 1 CARTON04/30/2014
21 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
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, dl- alpha- tocopherol acetate, 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
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON35 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL30 [iU]
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
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS124 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 0891
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)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
ROSEMARY (UNII: IJ67X351P9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
Product Characteristics
Colororange (caramel color) Scoreno score
ShapeCAPSULESize23mm
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 other04/30/2014
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893manufacture(0178-0891)

Revised: 1/2021
Document Id: b854765a-751f-2dc1-e053-2a95a90abb91
Set id: 06c529fc-272c-f889-f5e5-7f3e5ef2c59d
Version: 8
Effective Time: 20210107
 
Mission Pharmacal Company