Ferrex 150 Forte Plus

Generic Name: on, succinic acid, calcium ascorbate, calcium threonate, 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 Plus
Capsules

Rx Only

Ferrex 150 Forte Plus Description

Each Ferrex™ 150 Forte Plus Capsule contains:

*
Sumalate® (ferrous asparto glycinate) is a registered trademark of Albion International, Inc., Clearfield, Utah and is licensed exclusively to Breckenridge Pharmaceutical, Inc., for certain iron products.
Elemental Iron:
  (as Sumalate®*) 50 mg
  (as Polysaccharide Complex) 100 mg
Succinic Acid 50 mg
Vitamin C
  Ascorbic Acid (as Calcium Ascorbate) 60 mg
  Threonic Acid (as Calcium Threonate) 0.8 mg
Folic Acid, USP 1 mg
Vitamin B12 (Cyanocobalamin) 25 mcg

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

Indications and Usage for Ferrex 150 Forte Plus

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

Contraindications

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

Warnings

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.

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

Precautions

General

Do not exceed recommended dose.

The type of anemia and the underlying cause or causes should be determined before starting with Ferrex™ 150 Forte Plus. 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.

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.

Adverse Reactions

Adverse reactions with iron therapy 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.

Ferrex 150 Forte Plus Dosage and Administration

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

How is Ferrex 150 Forte Plus Supplied

Ferrex™ 150 Forte Plus capsules are available as a white/red capsule, imprinted B 798. Supplied in bottles of 90 capsules, NDC 51991-798-90.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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.

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

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

*U.S. Patent Nos. 5,516,925; 6,716,814
Other U.S. patents pending.

Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 USA

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

Rx Only

Rev. 11/09

PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-798-90

Ferrex 150
Forte Plus
Capsules

Rx Only

90 CAPSULES

FERREX 150   FORTE PLUS
iron, succinic acid, calcium ascorbate, calcium threonate, folic acid, and cyanocobalamin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-798
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON (IRON) IRON 150 mg
SUCCINIC ACID (SUCCINIC ACID) SUCCINIC ACID 50 mg
CALCIUM ASCORBATE (CALCIUM ASCORBATE) CALCIUM ASCORBATE 60 mg
CALCIUM THREONATE (CALCIUM THREONATE) CALCIUM THREONATE 0.8 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate  
Croscarmellose Sodium  
Crospovidone  
Anhydrous Dibasic Calcium Phosphate  
FD&C Blue No. 1  
FD&C Red No. 40  
Aluminum Oxide  
Gelatin  
Cellulose, Microcrystalline  
Polyethylene Glycol  
Povidone K30  
Silicon Dioxide  
Stearic Acid  
Titanium Dioxide  
Product Characteristics
Color RED (White/Red) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code B;798
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-798-90 90 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2008 09/30/2012
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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