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CitraNatal 90 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

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.

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.

CitraNatal 90 DHA Description

CitraNatal® 90 DHA 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 scored, white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “0821” on the other. The essential fatty acid DHA capsule 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) 159 mg
Iron (Carbonyl iron, ferrous gluconate) 90 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) 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 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® 90 DHA 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

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 90 DHA 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 SUPPLIED

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0821-30

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

Please consult your health care provider with any dietary concerns.



51072

C01 Rev 011130


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


CitraNatal®90 DHA Carton
NDC: 0178-0821-30

CitraNatal 90 DHA 
vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0178-0821
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 90 mg
VITAMIN D (CHOLECALCIFEROL) VITAMIN D 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 30 [iU]
THIAMINE (THIAMINE ION) THIAMINE 3 mg
RIBOPRINE (RIBOPRINE) RIBOPRINE 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
POTASSIUM TRIIODIDE (TRIIODIDE ION) POTASSIUM TRIIODIDE 150 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
CALCIUM CITRATE (CALCIUM CATION) CALCIUM CITRATE 159 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONES 152.5 mg
CELLULOSE, MICROCRYSTALLINE 60 mg
FERROUS GLUCONATE 44 mg
TITANIUM DIOXIDE 35.9 mg
CROSCARMELLOSE SODIUM 30 mg
ACRYLIC ACID 23.2 mg
MAGNESIUM SILICATE 11.8 mg
MAGNESIUM STEARATE 5.5 mg
THIAMINE MONONITRATE 4.54 mg
ETHYL VANILLIN 0.4 mg
VITAMIN A PALMITATE .01 mg
Product Characteristics
Color BROWN (caramel) Score 2 pieces
Shape CAPSULE Size 10mm
Flavor Imprint Code CN;90;0821
Contains         
Packaging
# Item Code Package Description
1 NDC:0178-0821-30 6 BLISTER PACK in 1 CARTON
1 5 BLISTER PACK in 1 BLISTER PACK
1 5 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/11/2014
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
Name Address ID/FEI Operations
Mission Pharmacal Company 927726893 MANUFACTURE(0178-0821)
Establishment
Name Address ID/FEI Operations
Robinson Pharma, Inc. 831560578 MANUFACTURE(0178-0821)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Limited 248441727 MANUFACTURE(0178-0821)
Revised: 10/2016
 
Mission Pharmacal Company
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