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Ferrex 150 Forte Prescribing Information

Package insert / product label
Generic name: iron, folic acid, and cyanocobalamin
Dosage form: capsule
Drug classes: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Mar 27, 2023.

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.

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 Acid1 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.

Warnings

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 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/Side Effects

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

PRINCIPAL DISPLAY PANEL - 100 Capsule Carton
FERREX 150 FORTE
iron, folic acid, and cyanocobalamin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51991-198
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON150 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN25 ug
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Croscarmellose Sodium (UNII: M28OL1HH48)
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Red No. 40 (UNII: WZB9127XOA)
Aluminum Oxide (UNII: LMI26O6933)
Gelatin (UNII: 2G86QN327L)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Polyethylene Glycol (UNII: 3WJQ0SDW1A)
Povidone K30 (UNII: U725QWY32X)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Stearic Acid (UNII: 4ELV7Z65AP)
Titanium Dioxide (UNII: 15FIX9V2JP)
Product Characteristics
ColorRED (Opaque Maroon) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeB;198
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51991-198-1110 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/200105/30/2012
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp.057795122MANUFACTURE