FOLIVANE-F- ferrous fumarate, iron, folic acid, ascorbic acid, and niacin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR), IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)

Available from:

Trigen Laboratories, LLC

INN (International Name):

ferrous fumarate

Composition:

FERROUS CATION 62.5 mg

Administration route:

ORAL

Therapeutic indications:

Folivane™-F is contraindicated in patients with a known hypersensitivity to any of the ingredients, also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

Product summary:

Folivane™-F is supplied in bottle of 90 capsules. Product Code: 13811-538-90

Authorization status:

Dietary Supplement

Summary of Product characteristics

FOLIVANE-F- FERROUS FUMARATE, IRON, FOLIC ACID, ASCORBIC ACID, AND
NIACIN CAPSULE
TRIGEN LABORATORIES, LLC
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FOLIVANE™-F
WITH ASCORBIC ACID PRECURSORS
SUPPLEMENT FACTS
Folivane™-F is a professionally prescribed iron, folic acid, and
vitamin supplement used
to improve the nutritional status of patients with iron and/or folate
deficiency anemia,
including women in the prenatal and postnatal period. DO NOT
ADMINISTER TO CHILDREN
UNDER THE AGE OF 12.
CONTRAINDICATIONS
Folivane™-F is contraindicated in patients with a known
hypersensitivity to any of the
ingredients, also, all iron compounds are contraindicated in patients
with hemosiderosis,
hemochromatosis, or hemolytic anemias. Pernicious anemia is a
contraindication, as folic
acid may obscure its signs and symptoms.
WARNINGS
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.
PRECAUTIONS
GENERAL: Folic acid alone is improper therapy in the treatment of
pernicious anemia and
other megaloblastic anemias where B
is deficient. Anemia requires appropriate
investigation to determine its cause or causes. Periodic clinical and
laboratory studies
are considered essential. Blood tests including hemoglobin and
hematocrit should be
done to determine the adequacy of therapy. Folic acid should be used
with care in the
presence of peptic ulcer disease, regional enteritis, and ulcerative
colitis. In doses above
0.1 mg daily, folic acid may obscure the diagnosis of pernicious
anemia.
USAGE IN PREGNANCY
Before Folivane™-F is prescribed for megaloblastic anemia in
pregnancy, appropriate
diagnostic exclusion of Addisonian pernicious anemia (due to faulty or
blocked
absorption of vitamin B
, or extrinsic factor or either a genetic, immunological or
surgical basis) should be carried out.
PEDIATRIC USE: Safety and effectiveness of this product have not been
established in
pediatric