STATEMENT OF IDENTITY: MV: Iron Fumarate & Aspartate, Glycinate/Ascorbic Calcium/Vitamin B12/Folic Acid/Calcium Threonate/Succinic Acid (151 mg-60 mg-10 mcg-1 mg-0.8 mg-50 mg) is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs for iron deficiencies and/or nutritional megaloblastic anemias.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

DOSAGE AND ADMINISTRATION: The usual adult dose is 1 tablet daily with or without food or as directed by a licensed medical practitioner.

Other ingredients: Dicalcium Phosphate granular (Min 23% Ca), Stearic Acid Kosher, Croscarmellose Sodium Kosher, Microcrystalline Cellulose Kosher, Silicon Dioxide Kosher, Magnesium Stearate Kosher, FD&C Red # 40 (Lakes), FD&C Blue No. 2 Aluminum Lake, FD&C Yellow Lake No. 5 and other ancillary ingredients as needed to ensure product stability.

How Supplied: MV: Iron Fumarate & Aspartate, Glycinate/Ascorbic Calcium/Vitamin B12/Folic Acid/Calcium Threonate/Succinic Acid (151 mg-60 mg-10 mcg-1 mg-0.8 mg-50 mg) is a brown tablet embossed with "V215", supplied in bottles of 90 tablets.

PRECAUTIONS/WARNING: WARNINGS: Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population. Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group. Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study. Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.

PRECAUTIONS: Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress.

STORAGE: Store at controlled room temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.

HEALTH CLAIMS: Prescription Vitamin B and Iron Containing Dietary Supplement

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIRTUS
PHARMACEUTICALS

NDC† 76439-215-90

MV: Iron Fumarate &
Aspartate, Glycinate/
Ascorbic Calcium/
Vitamin B12/Folic Acid/
Calcium Threonate/
Succinic Acid

(151 mg-60 mg-10 mcg-1 mg-0.8 mg-50 mg)

Prescription Dietary Supplement

Rx

90 Tablets      Made in USA