FerroGels Forte
Generic Name: ascorbic acid, folic acid, cyanocobalamin, and ferrous fumarate
Dosage Form: capsule, liquid filled
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.
FerroGels Forte Softgels
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
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.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage and Administration
One softgel daily or as directed by a physician.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
Store at controlled room temperature 15o-30o C (59o-86oF).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:
Cypress Pharmaceutical, Inc., Madison, MS 39110
B032 Rev 09/02
FerroGels Forte
Vitamin and Iron Supplement
Rx Only
Cypress Pharmaceutical, Inc.
100 SoftGels
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| Labeler - Cypress Pharmaceutical, Inc. (790248942) |
| Registrant - Cypress Pharmaceutical, Inc. (790248942) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Accucaps Industries Limited | 248441727 | manufacture | |
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