NATALVIRT CA

Virtus Pharmaceuticals

NATALVIRT™ CA

FULL PRESCRIBING INFORMATION: CONTENTS*

• NATALVIRT CA DESCRIPTION
• INDICATIONS
• NATALVIRT CA CONTRAINDICATIONS
• WARNING
• CAUTION
• WARNING
• PRECAUTIONS
• NATALVIRT CA ADVERSE REACTIONS
• NATALVIRT CA 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 CA DESCRIPTION

NATALVIRT™ CA 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 "V244" on one side. The essential fatty acid DHA capsule is oblong and clear with yellowish oil inside.

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).

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

NATALVIRT CA CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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 CA ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

NATALVIRT CA 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 76439-244-60.

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 76439-244-60

NATALVIRT™ CA

Rx Prenatal Vitamin Tablet and 300 mg DHA capsule

Rx
30 Tablets
30 Soft Gelatin Capsules