NATALVIRT 90DHA
NATALVIRT™ 90 DHA
FULL PRESCRIBING INFORMATION: CONTENTS*
- NATALVIRT 90DHA DESCRIPTION
- INDICATIONS
- NATALVIRT 90DHA CONTRAINDICATIONS
- WARNING
- CAUTION
- WARNING
- PRECAUTIONS
- NATALVIRT 90DHA ADVERSE REACTIONS
- NATALVIRT 90DHA DOSAGE AND ADMINISTRATION
- Storage
- NOTICE
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - Kit Carton
FULL PRESCRIBING INFORMATION
Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule
NATALVIRT 90DHA 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: | |
|---|---|
| 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.
NATALVIRT 90DHA 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.
NATALVIRT 90DHA ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
NATALVIRT 90DHA 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 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 90DHACALCIUM 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
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