Natalvirt 90 DHA
Name: Natalvirt 90 DHA
NATALVIRT™ 90 DHA
Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule
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.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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
