ZINTREXYL-C- ferrous fumarate, folic acid tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), P

Available from:

PureTek Corporation

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zintrexyl-C TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence. This product is contraindicated in patients with known hypersensitivity to any of its 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:

Zintrexyl-C TM are yellow with slightly brown speckled, coated caplets. Bottles contain 60 caplets – NDC 59088-180-58. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

Authorization status:

unapproved drug other

Summary of Product characteristics

ZINTREXYL-C- FERROUS FUMARATE, FOLIC ACID TABLET
PURETEK CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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ZINTREXYL-C™
DESCRIPTION:
FULL PRESCRIBING INFORMATION:
EACH SERVING SIZE OF 2 CAPLETS CONTAIN:
OTHER INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide,
Crospovidone,
Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose
Monohydrate,
Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow
#6/Sunset Yellow FCF
Aluminum Lake).
INDICATIONS:
ZINTREXYL-C
is indicated for the treatment of iron deficiency anemia and folate
deficiency as in extended convalescence, menorrhagia, pregnancy,
puberty, excessive
blood loss, and advanced age. Also for the treatment of the condition
in which iron
deficiency and vitamin C deficiency occur together, along with a
deficient intake or
increased need for B-Complex vitamins in chronic and acute illness, as
well as cases of
metabolic stress, and in convalescence.
TM
CONTRAINDICATIONS:
This product is contraindicated in patients with known
hypersensitivity to any of its
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.
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.
Administration of folic acid
alone is improper therapy for pernicious anemia and other
megaloblastic anemias in
which vitamin B12 is deficient.
PRECAUTION SECTION
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia,
in that
hematologic remission can occur while neurological manifestations
remain progressive.
There is a potential danger in administering folic