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NATALVIRT 90DHA (doconexent 300 mg) Dailymed



IMPRINT: V245     SHAPE: oval
    COLOR: white

Boxed Warning

Boxed Warning Section

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.


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Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

Description


NATALVIRTâ„¢ 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) Derived from fish oil containing less than 1% EPA. 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


NATALVIRTâ„¢ 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.

Boxed Warning Section


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.

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 buler 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, LLCTampa, Florida 33619

Made In Canada

12/12

Principal Display Panel - Kit Carton


VIRTUS PHARMACEUTICALS

NDC 76439-245-60

NATALVIRTâ„¢ 90 DHA

Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

Rx 30 Tablets30 Soft Gelatin Capsules

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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