TRIGELS-F FORTE- folic acid, ascorbic acid, cyanocobalamin, and ferrous fumarate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Folic Acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), Ascorbic Acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), Cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204), Ferrous Fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)

Available from:

Trigen Laboratories, LLC

INN (International Name):

Folic Acid

Composition:

Folic Acid 1 mg

Administration route:

ORAL

Therapeutic indications:

Trigels-F Forte should not be used by patients with a known hypersensitivity to any of the listed ingredients including soy.  All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias.

Product summary:

Trigels-F Forte is available in child resistant blister packs of 100 (10 x 10) softgel capsules. Product Code: 13811-518-10

Authorization status:

Dietary Supplement

Summary of Product characteristics

TRIGELS-F FORTE- FOLIC ACID, ASCORBIC ACID, CYANOCOBALAMIN, AND
FERROUS
FUMARATE CAPSULE
TRIGEN LABORATORIES, LLC
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TRIGELS-F
FORTE
DESCRIPTION
OTHER INGREDIENTS: Soybean Oil, Gelatin, Glycerin, Purified Water,
Yellow Beeswax, Soy
Lecithin, Ethyl Vanillin, Titanium Dioxide, FD&C Red #40, FD&C Yellow
#5, FD&C Blue #1
THIS PRODUCT CONTAINS SOY.
Trigels-F Forte is a prescription vitamin used for the dietary
management of patients with
nutritional deficiencies or are in need of nutritional
supplementation.
INACTIVE INGREDIENTS
Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Beeswax,
Lecithin, Ethyl Vanillin,
Titanium Dioxide, FD&C Red #40, FD&C Yellow #5, FD&C Blue #1.
CONTRAINDICATIONS
Trigels-F Forte should not be used by patients with a known
hypersensitivity to any of
the listed ingredients including soy. All iron compounds are
contraindicated in patients
with hemochromatosis, hemosiderosis, or hemolytic 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.
PRECAUTIONS
Do not exceed recommended dose. The type of anemia and the underlying
cause or
causes should be determined before starting therapy with Trigels-F
Forte. Since the
anemia may be a result of a systemic disturbance, such as recurrent
blood loss, the
underlying cause or causes should be corrected, if possible.
FOLIC ACID: Folic acid alone is improper therapy in the treatment of
pernicious anemia
and other megaloblastic anemias where vitamin B
is deficient. Folic acid in doses above
0.1 mg daily may obscure pernicious anemia in that hematologic
remission can occur
while neurologic manifestations remain progressive.
The patient’s medical conditions and consumption of other drugs,
herbs, and/or
supplements should be considered.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause
allergic-type
reactions (including bronchial as