FerroGels Forte

Cypress Pharmaceutical, Inc.
Cypress Pharmaceutical, Inc.

FerroGels Forte Softgels

FULL PRESCRIBING INFORMATION: CONTENTS*

• Description
• FerroGels Forte Indications and Usage
• Contraindications
• Warnings
• Precautions
• Side Effects
• Dosage and Administration
• How Supplied
• Storage

FULL PRESCRIBING INFORMATION

Description

FerroGels Forte are brown oblong soft gelatin capsules containing a reddish-orange to brown paste.  These soft gels provide water-soluble vitamins and iron.  These softgels also contain the following inactive ingredients: blue 1 lake, gelatin, glycerin, hydrogenated soybean oil, lecithin, red 40 Lake, soybean oil, starch, titanium dioxide, vegetable shortening, yellow 6 Lake, yellow beeswax.

Each softgel contains:

Vitamin C (as ascorbic Acid)..............60 mg

Folic Acid.........................................1 mg

Vitamin B₁₂ (as cyanocobalamin)......10 mcg

Iron (as ferrous fumarate).................151 mg

FerroGels Forte Indications and Usage

For the treatment of iron deficiency anemia and folate deficiency anemia.  FerroGels Forte is indicated in pregnancy for the prevention and treatment of iron deficiency and to supply a maintenance dosage of folic acid.

Contraindications

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

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B₁₂ is deficient.

WARNING: Accidental overdose of iron containing product 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

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Side Effects

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

Dosage and Administration

How Supplied

FerroGels Forte softgels for oral administration are available in child-resistant unit dose packs of 100 softgels (10 cards of 2 x 5 blisters), imprinted with "CYP 189", NDC 60258-189-01.

Storage