Medication Guide App

Iferex 150 Forte

Dosage form: capsule
Ingredients: IRON 150mg, CYANOCOBALAMIN 25mg, FOLIC ACID 1mg
Labeler: Nnodum Pharmaceuticals
NDC Code: 63044-198

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.

IFEREX 150 Forte

Polysaccharide Iron Complex

Hematinic Capsules

NDC 63044-0198-01

WARNING:

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this products out of the reach of children. In case of accidental overdose, call a doctor or poison control immediately.

Rx Only

DESCRIPTION:

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

INDICATIONS:

For treatment of iron deficiency anemia and/or nutritional megaloblastic anemias due to inadequate diet.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin 812 is deficient. Keep out of the reach of children. Close tightly and keep out of reach of children. Contains iron, which can be harmful or fatal to children in large doses.

PRECAUTIONS:

Folic acid in doses above 0..1 mg - 0..4 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use Safety and effectiveness in pediatric patients has not been established.

GERIATRIC USE:

Clinical studies on this product have not been performed in sufficient numbers of 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 therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION:

Adults: One capsule daily or as directed by a physician.

Each capsule contains:
Iron (Elemental)    150 mg
(as polysaccharide-iron complex)
Folic Acid     1 mg
Vitamin 812        25 mc

OTHER INGREDIENTS: Microcrystalline Cellulose,Gelatin,Magnesium Strearate, D&C Red #28, Titanium Dioxide, FD&C red #3, D&C Yellow #10, and FD&C Blue # 1

HOW SUPPLIED

IFEREX 150 Forte Capsules are Opaque maroon cap/opaque maroon NDC 63044-0198-01.

Supplied in 100 count bottle.

STORAGE: Store at controlled 20°C - 25°C (68°-77°F); excursions permitted to 15°C-30°C (59°- 86°F).

Manufactured for
Nnodum Pharmaceuticals
Cincinnati, Ohio 45229

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
IFEREX 150 FORTE 
iron, cyanocobalamin and folic acid capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63044-198
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRON (IRON) IRON150 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
GELATIN 
MAGNESIUM STEARATE 
D&C RED NO. 28 
TITANIUM DIOXIDE 
FD&C RED NO. 3 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
Product Characteristics
ColorBROWN (maroon) Scoreno score
ShapeCAPSULESize7mm
FlavorImprint CodeZ198
Contains    
Packaging
#Item CodePackage Description
1NDC:63044-198-01100 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/28/2007
Labeler - Nnodum Pharmaceuticals (960457273)
Establishment
NameAddressID/FEIOperations
JLM Pharmatech966721805MANUFACTURE

Revised: 12/2011
 
Nnodum Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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