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CitraNatal DHA

Generic Name: vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium
Dosage Form: tablet, soft gel capsule

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® DHA

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.

CitraNatal DHA Description

CitraNatal® DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of an essential fatty acid. The prenatal vitamin is a white, scored, oval multi-vitamin/mineral tablet. The tablet is debossed “CN 1” on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture.

Each prenatal tablet contains:
Vitamin C (Ascorbic acid) 120 mg
Calcium (Calcium citrate) 124 mg
Iron (Carbonyl iron, ferrous gluconate) 27 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) 20 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 soft gel contains:
Other ingredients in DHA soft gel: High oleic sunflower oil, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.
Docosahexaenoic Acid (DHA, 40% from 625 mg Algal Oil) 250 mg
Eicosapentaenoic Acid (EPA) Not more than 0.625 mg

INDICATIONS

CitraNatal® DHA is a multi-vitamin/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:
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.

DOSAGE AND ADMINISTRATION

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

STORAGE

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimalized.

NOTICE: Contact with moisture can discolor or erode the tablet.

How is CitraNatal DHA Supplied

Six child-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0894-30.

To report a serious adverse event or obtain product information, call (210) 696-8400.

Please consult your health care provider with any dietary concerns.



500243
C01 Rev 002140


DHA soft gels 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 © 2014 Mission Pharmacal Company.
All rights reserved.

Citranatal DHA
Rx Prenatal Vitamin Tablet
and 250 mg DHA Soft Gel
Carton

NDC 0178–0894–30

Blister Pack

CitraNatal DHA 
vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0178-0894
Packaging
# Item Code Package Description
1 NDC:0178-0894-30 30 BLISTER PACK in 1 CARTON
1 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 
vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
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
CALCIUM CITRATE (CALCIUM CATION) CALCIUM CITRATE 124 mg
IRON (IRON) IRON 27 mg
VITAMIN D (CHOLECALCIFEROL) VITAMIN D 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 30 [iU]
THIAMINE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 150 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONES  
CROSCARMELLOSE SODIUM  
TITANIUM DIOXIDE  
MAGNESIUM SILICATE  
SHELLAC  
POLYETHYLENE GLYCOLS  
ETHYL VANILLIN  
VITAMIN A PALMITATE  
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL (modified oval) Size 20mm
Flavor Imprint Code CN;1
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/22/2014
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 250 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 0.625 mg
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL  
LECITHIN, SUNFLOWER  
ROSEMARY  
TOCOPHEROL  
ASCORBYL PALMITATE  
Product Characteristics
Color BROWN (caramel) 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
Dietary Supplement 05/22/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/22/2014
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
Name Address ID/FEI Operations
Mission Pharmacal Company 927726893 MANUFACTURE(0178-0894)
Establishment
Name Address ID/FEI Operations
Robinson Pharma, Inc. 831560578 MANUFACTURE(0178-0894)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Limited 248441727 MANUFACTURE(0178-0894)
Revised: 05/2014
 
Mission Pharmacal Company
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