CITRANATAL 90 DHA- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet 
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® 90 DHA

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.

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 “08” bisect “29” 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)160 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 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: High Oleic Sunflower Oil, 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.

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 0178-0829-30

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



50261

C01 Rev 011110


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: 0178-0829-30

ingredient-listing-for-labels-110909
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0829
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 CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE160 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON90 mg
VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL30 [iU]
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
RIBOPRINE (UNII: 8EU82FAZ5J) (RIBOPRINE - UNII:8EU82FAZ5J) RIBOPRINE3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE20 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
POTASSIUM TRIIODIDE (UNII: T66M6Y3KSA) (TRIIODIDE ION - UNII:DA1N05631Q) POTASSIUM TRIIODIDE150 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES (UNII: FZ989GH94E) 152.5 mg
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 60 mg
FERROUS GLUCONATE (UNII: U1B11I423Z) 44 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 35.9 mg
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 30 mg
NIACINAMIDE (UNII: 25X51I8RD4) 26.6 mg
ACRYLIC ACID (UNII: J94PBK7X8S) 23.2 mg
MAGNESIUM SILICATE (UNII: 9B9691B2N9) 11.8 mg
MAGNESIUM STEARATE (UNII: 70097M6I30) 5.5 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) 4.54 mg
SHELLAC (UNII: 46N107B71O) 2.5 mg
ETHYL VANILLIN (UNII: YC9ST449YJ) 0.4 mg
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .01 mg
Product Characteristics
ColorBROWN (caramel) Score2 pieces
ShapeCAPSULESize10mm
FlavorImprint Code CN;90
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0829-306 in 1 CARTON
15 in 1 BLISTER PACK
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/01/2010
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893MANUFACTURE(0178-0829)
Establishment
NameAddressID/FEIBusiness Operations
Robinson Pharma, Inc.831560578MANUFACTURE(0178-0829)
Establishment
NameAddressID/FEIBusiness Operations
Accucaps Industries Limited248441727MANUFACTURE(0178-0829)

Revised: 3/2013
Document Id: 62d662f4-a16f-fca3-3bd7-2a407c7bbd13
Set id: 62d662f4-a16f-fca3-3bd7-2a407c7bbd13
Version: 1
Effective Time: 20130325
 
Mission Pharmacal Company