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CitraNatal DHA

Dosage form: tablet
Ingredients: ASCORBIC ACID 120mg, CALCIUM CITRATE 125mg, IRON 27mg, VITAMIN D 400[iU], .ALPHA.-TOCOPHEROL ACETATE 30[iU], THIAMINE 3mg, RIBOFLAVIN 3.4mg, NIACINAMIDE 20mg, PYRIDOXINE HYDROCHLORIDE 20mg, FOLIC ACID 1mg, POTASSIUM IODIDE 150mg, ZINC OXIDE 25mg, CUPRIC OXIDE 2mg, DOCUSATE SODIUM 50mg
Labeler: Mission Pharmacal Company
NDC Code: 0178-0898

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.

DESCRIPTION

CitraNatal® 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 white, scored, oval multivitamin/mineral tablet. The tablet is debossed “CN RX” 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 tablet contains:
Vitamin C (Ascorbic acid)120 mg
Calcium (Calcium citrate)125 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 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 625 mg Algal Oil) 250 mg Eicosapentaenoic Acid (EPA)................. Not more than 0.625 mg Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.

INDICATIONS

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CONTRAINDICATIONS

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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 0178-0898-30

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

500238

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® DHA Carton
NDC: 0178-0898-30

CITRANATAL 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:0178-0898
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID120 mg
CALCIUM CITRATE (CALCIUM CATION) CALCIUM CITRATE125 mg
IRON (IRON) IRON27 mg
VITAMIN D (CHOLECALCIFEROL) VITAMIN D400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL30 [iU]
THIAMINE (THIAMINE ION) THIAMINE3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE150 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION2 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES132.2 mg
CROSCARMELLOSE SODIUM30.6 mg
TITANIUM DIOXIDE30.5 mg
NIACINAMIDE25 mg
MAGNESIUM SILICATE5.1 mg
THIAMINE MONONITRATE3.9 mg
SHELLAC2.6 mg
POLYETHYLENE GLYCOLS2 mg
ETHYL VANILLIN.7 mg
VITAMIN A PALMITATE.15 mg
VITAMIN D.02 mg
Product Characteristics
ColorBROWN (caramel) Score2 pieces
ShapeCAPSULESize10mm
FlavorImprint CodeCN;RX
Contains    
Packaging
#Item CodePackage Description
1NDC:0178-0898-306 BLISTER PACK in 1 CARTON
15 BLISTER PACK in 1 BLISTER PACK
15 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/20/2007
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIOperations
Mission Pharmacal Company927726893MANUFACTURE(0178-0898)
Establishment
NameAddressID/FEIOperations
Robinson Pharma, Inc.831560578MANUFACTURE(0178-0898)
Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited248441727MANUFACTURE(0178-0898)

Revised: 03/2013
 
Mission Pharmacal Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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