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.

Slideshow: Fact or Fiction? The Top 15 Osteoarthritis Myths

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
NDC 60258-189-01

FerroGels Forte


Vitamin and Iron Supplement

Rx Only

Cypress Pharmaceutical, Inc.

100 SoftGels


FerroGels Forte 
ascorbic acid, folic acid, cyanocobalamin, and ferrous fumarate capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60258-189
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 10000 ng
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE 151 mg
Product Characteristics
Color brown Score no score
Shape CAPSULE (CYP;189) Size 22mm
Flavor Imprint Code CYP;189
Contains         
Packaging
# Item Code Package Description
1 NDC:60258-189-01 100 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 08/01/2002
Labeler - Cypress Pharmaceutical, Inc. (790248942)
Registrant - Cypress Pharmaceutical, Inc. (790248942)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Limited 248441727 manufacture
Revised: 10/2009
 
Cypress Pharmaceutical, Inc.
Hide
(web1)