Ferrex 28

ascorbic acid, folic acid, cyanocobalamin, iron, ferrous fumurate and succinic acid

Dosage Form: tablet
Ferrex™ 28

ONCE-DAILY

Rx Only

Ferrex 28 Description

Ferrex™ 28 Tablets for oral administration to provide 28-day iron supplement therapy.

Each maroon film-coated tablet contains:

Vitamin C (Ascorbic Acid) .................................... 140 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) ................................10 mcg

Iron (as Ferrous Asparto Glycinate) .......................... 70 mg

Iron (as Ferrous Fumarate)........................................ 81 mg

Succinic Acid.......................................................... 150 mg

Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake1, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Pharmaceutical Glaze, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Soy Polysaccharide, Stearic Acid and Titanium Dioxide.

Allergen: Contains Soy.

Each blue film-coated tablet contains:

Succinic Acid..................................................... 150 mg

Inactive Ingredients: Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, FD&C Blue No. 1 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Silica, Soy Polysaccharide, Stearic Acid, Titanium Dioxide and Triacetin.

Allergen: Contains Soy.

1

This product contains FD&C Yellow No. 6 Lake as a color additive.

Indications and Usage for Ferrex 28

For the nutritional supplementation of anemias responsive to oral iron, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron supplementation.

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 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 taking Ferrex™ 28 Tablets. 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

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 supplementation.

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 supplementation may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron supplementation 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 28 Dosage and Administration

Usual adult dose is 1 tablet daily, or as directed by a physician. Ferrex™ 28 supplies a 28 day course of iron supplementation that consists of 21 maroon active tablets and 7 blue absorption period tablets. Take 1 maroon tablet daily for 21 days, followed by 1 blue tablet daily for 7 days. After 28 tablets have been taken, a new course may be started if prescribed.

How is Ferrex 28 Supplied

Ferrex™ 28 Tablets are available as 21 maroon active tablets debossed "B 586" and 7 blue absorption period tablets debossed "B 587". Supplied in packages of 28 tablets each containing 4 child-resistant blisters of 7 tablets. NDC 51991-588-28.

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.

Storage and Handling

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.

Rx Only

Manufactured by:

Contract Pharmacal Corp.

Hauppauge, NY 11788 USA

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

Iss. 05/09

PRINCIPAL DISPLAY PANEL - Carton

Breckenridge

Pharmaceutical, Inc.

NDC 51991-588-28

Ferrex™ 28

ONCE-DAILY

Rx Only

28 Tablets

(21 active, 7 absorption period tablets)

Ferrex 28  ascorbic acid, folic acid, cyanocobalamin, iron, ferrous fumurate and succinic acid  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-588

Packaging # NDC Package Description Multilevel Packaging 1 51991-588-28 1 KIT In 1 BLISTER PACK None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1   21  Part 2   7

Part 1 of 2 Ferrex 28  ascorbic acid, folic acid, cyanocobalamin, iron, ferrous fumurate and succinic acid  tablet, coated

Product Information       Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 200 mg Folic Acid (Folic Acid) Folic Acid 1 mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 10 ug Iron (Iron) Iron 70 mg Ferrous Fumarate (Iron) Ferrous Fumarate 81 mg Succinic Acid (Succinic Acid) Succinic Acid 150 mg

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   FD&C Yellow No. 6   Hypromelloses   Magnesium Silicate   Magnesium Stearate   Cellulose, Microcrystalline   Mineral Oil   Shellac   Polyethylene Glycol   Silicon Dioxide   Sodium Lauryl Sulfate   Stearic Acid   Titanium Dioxide

Product Characteristics Color RED Score 2 pieces Shape OVAL Size 7mm Flavor Imprint Code B;586 Contains

Packaging # NDC Package Description Multilevel Packaging Package Information Not Applicable

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/26/2009 07/31/2011

Part 2 of 2 SUCCINIC ACID  succinic acid  tablet, coated

Product Information       Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Succinic Acid (Succinic Acid) Succinic Acid 150 mg

Inactive Ingredients Ingredient Name Strength Croscarmellose Sodium   Crospovidone   Anhydrous Dibasic Calcium Phosphate   FD&C Blue No. 1   Aluminum Oxide   Hypromelloses   Magnesium Silicate   Magnesium Stearate   Cellulose, Microcrystalline   Mineral Oil   Silicon Dioxide   Stearic Acid   Titanium Dioxide   Triacetin

Product Characteristics Color BLUE Score 2 pieces Shape OVAL Size 7mm Flavor Imprint Code B;587 Contains

Packaging # NDC Package Description Multilevel Packaging Package Information Not Applicable

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/26/2009 07/31/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/26/2009	07/31/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmacal Corporation		057795122	MANUFACTURE

Revised: 01/2011Breckenridge Pharmaceutical, Inc.

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