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Ferrex 150 Forte

Generic Name: iron, folic acid, and cyanocobalamin
Dosage Form: capsule

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.

Ferrex 150
Forte
Capsules

Ferrex 150 Forte Description

Ferrex™ 150 Forte Capsules are a highly water soluble complex of iron/low molecular weight polysaccharide and vitamins.

Each Ferrex™ 150 Forte Capsule contains:

Elemental Iron (as Polysaccharide Iron) 150 mg
Folic Acid 1 mg
Vitamin B12 (Cyanocobalamin) 25 mcg

Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Dicalcium Phosphate, FD&C Blue No.1 Lake, FD&C Red No. 40 Lake, Gelatin, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinylpyrrolidone, Sodium Lauryl Sulfate, Stearic Acid and Titanium Dioxide.

Ferrex 150 Forte Dosage and Administration

Usual adult dosage is 1 capsule daily, or as directed by a physician.

Indications and Usage for Ferrex 150 Forte

Ferrex™ 150 Forte is indicated for the dietary management of iron deficiency anemia and/or nutritional megaloblastic anemias.

Contraindications

Ferrex™ 150 Forte is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron supplementation.

Warning

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 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

General

Do not exceed recommended dose.

The type of anemia and the underlying cause or causes should be determined before starting Ferrex™ 150 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 in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

Adverse reactions with iron supplementation may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient.

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

Overdosage

The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

How is Ferrex 150 Forte Supplied

Ferrex™ 150 Forte capsules are available as an opaque maroon capsule, imprinted B 198. Supplied in Unit Dose blister packs, 10 capsules per card, NDC 51991-198-11.

Warning: Keep this and all medications out of the reach of children.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Protect from light and moisture.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx Only

Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 USA
www.cpc.com
Rev. 08/09

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

PRINCIPAL DISPLAY PANEL - 100 Capsule Carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-198-11

Ferrex™ 150
Forte
Capsules

Rx Only

100 CAPSULES

(10 x 10) Unit Dose

FERREX 150   FORTE
iron, folic acid, and cyanocobalamin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-198
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON (IRON) IRON 150 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate  
Croscarmellose Sodium  
Anhydrous Dibasic Calcium Phosphate  
FD&C Blue No. 1  
FD&C Red No. 40  
Aluminum Oxide  
Gelatin  
Cellulose, Microcrystalline  
Polyethylene Glycol  
Povidone K30  
Sodium Lauryl Sulfate  
Stearic Acid  
Titanium Dioxide  
Product Characteristics
Color RED (Opaque Maroon) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code B;198
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-198-11 10 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 10 CAPSULE (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/01/2001 05/30/2012
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Contract Pharmacal Corp. 057795122 MANUFACTURE
Revised: 03/2011
 
Breckenridge Pharmaceutical, Inc.
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