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Natalvirt 90 DHA

Generic Name: calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, ascorbic acid, thiamine, riboflavin, niacinamide, iodine, zinc, copper, and doconexent
Dosage Form: 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.

NATALVIRT™ 90 DHA

Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

Natalvirt 90 DHA Description

NATALVIRT™ 90 DHA is an orally administered prescription PRENATAL/POSTNATAL multivitamin/mineral tablet with dual iron, calcium, and other dietary ingredients, and a soft gelatin capsule of an essential fatty acid. The prenatal vitamin is a white, coated, oval multivitamin/mineral tablet. The tablet is debossed "V245" on one side. The essential fatty acid DHA capsule is oblong and clear with yellowish oil inside.

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 Acid 1 mg
Iodine (Potassium iodide) 150 mcg
Zinc (Zinc oxide) 25 mg
Copper (Cupric oxide) 2 mg
Docusate Sodium 50 mg

Other Ingredients (tablet): Citric Acid, Croscarmellose Sodium, Fumed Silica, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Silicon Dioxide, Stearic Acid, TriPotassium Citrate, White Coating (Hypromellose, Polyethylene Glycol, PVA, Talc, Titanium Dioxide).

Each DHA gelatin capsule contains:
*
Derived from fish oil containing less than 1% EPA.
Docosahexaenoic Acid (DHA)* 300 mg

Other ingredients (DHA softgel): Ethyl Vanillin, Gelatin, Glycerin, Purified Water, Vitamin E.

This product contains fish (tuna) oil. However, the fish oil used in this product does not contain detectable levels of fish protein. Nevertheless, individuals with allergic tendencies to fish should use discretion and consult their healthcare practitioner for advice.

This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, eggs, wheat, milk, soy, and shellfish. Individuals with allergic tendencies to these substances should use discretion.

This product also contains bovine gelatin.

INDICATIONS

NATALVIRT™ 90 DHA is a prescription multivitamin/mineral indicated for use in improving the nutritional status of women prior conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating 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.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

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.

Natalvirt 90 DHA Dosage and Administration

One tablet and one capsule daily or as directed by a licensed medical practitioner.

Storage

Store at controlled room temperature. Protect from light and moisture. Dispense in a tight, light-resistant container.

NOTICE

Contact with moisture can discolor or erode the tablet.

How is Natalvirt 90 DHA Supplied

Child-resistant blister packs of 30 tablets and 30 capsules. NDC 76439-245-60.

Call your medical practitioner about side effects. You may report side effects by calling (813) 283-1344.

KEEP THIS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable.

This is not an Orange Book product.

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619

Made In Canada

12/12

PRINCIPAL DISPLAY PANEL - Kit Carton

VIRTUS
PHARMACEUTICALS

NDC 76439-245-60

NATALVIRT™ 90 DHA

Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

Rx
30 Tablets
30 Soft Gelatin Capsules

NATALVIRT 90DHA 
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, ascorbic acid, thiamine, riboflavin, niacinamide, iodine, zinc, copper, and doconexent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-245
Packaging
# Item Code Package Description
1 NDC:76439-245-60 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BLISTER PACK 30 
Part 2 1 BLISTER PACK 30 
Part 1 of 2
NATALVIRT 90DHA 
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, ascorbic acid, thiamine, riboflavin, niacinamide, iodine, zinc, and copper tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CITRATE (CALCIUM CATION) CALCIUM 160 mg
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 90 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
THIAMINE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 150 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate  
Croscarmellose Sodium  
Silicon Dioxide  
Magnesium Stearate  
Cellulose, Microcrystalline  
Starch, Corn  
Stearic Acid  
Potassium Citrate Anhydrous  
Titanium Dioxide  
Hypromelloses  
Polyethylene Glycols  
Polyvinyl Alcohol  
Talc  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 21mm
Flavor Imprint Code V245
Contains         
Packaging
# Item Code Package Description
1 30 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/25/2013
Part 2 of 2
NATALVIRT 90DHA 
doconexent capsule, gelatin coated
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
Inactive Ingredients
Ingredient Name Strength
.Alpha.-Tocopherol  
Water  
Ethyl Vanillin  
Gelatin  
Glycerin  
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 19mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/25/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/15/2013
Labeler - Virtus Pharmaceuticals (969483143)
Revised: 02/2013
 
Virtus Pharmaceuticals
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