Your browser does not support JavaScript! IFEREX 150 (POLYSACCHARIDE-IRON COMPLEX) CAPSULE [NNODUM PHARMACEUTICALS]
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IFEREX 150 (polysaccharide-iron complex) capsule
[Nnodum Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

(Polysaccharide-Iron Complex) Hematinic

NDC 63044-0203-61

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

DESCRIPTION:

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

ACTIONS AND USES: IFEREX™ 150 is an easily assimilated source of iron for treatment of uncomplicated iron deficiency anemia. Because IFEREX™ 150 is a polysaccharide bound iron complex, it is relatively nontoxic and there are relatively few, if any, gastrointestinal side effects associated with iron therapy, thus permitting full therapeutic dosage (150 - 300 mg elemental iron daily) in a single dose if desirable. There is no staining of teeth and no metallic aftertaste.

INDICATIONS:

Iferex 150 is indicated for the prevention and treatment of iron deficiency anemia and / or nutritional megalobastic anemias.

CONTRAINDICATIONS:

In patients with hemochromatosis and hemosiderosis and in those with known hypersensitivity to any of the ingredients.

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.

WARNINGS:

Keep out of reach of children. Contains iron, which can be harmful or fatal to children in large doses.

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.

DOSAGE AND ADMINISTRATION:

Adults - 1 to 2 capsules daily; pediatric patients, as directed by a physician.

HOW SUPPLIED:

IFEREX™ 150 Capsules are  brown cap/opaque orange body imprinted “ZIKS” (Cap)/”0203” (body), NDC 63044-0203-61 Supplied in Unit Dose Packs containing 10 capsules per card.

Each capsule contains:

Iron (Elemental) . . . . . . . . . . . . . . . . . . . . . . . . . 150 mg

(as polysaccharide-iron complex)

INACTIVE INGREDIENTS:

Black Iron oxide,FD&C Red #28, FD&C Yellow # 10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, magnesium stearate, microcrystalline cellulose,Red Iron Oxide, and Titanium Dioxide

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

Storage: Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured for
Nnodum  Pharmaceutical
Cincinnati, Ohio 45229

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

53257303-figure-01
53257303-figure-02
IFEREX 150 
polysaccharide-iron complex capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63044-203
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRON (IRON) IRON150 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
D&C BLUE NO. 1 
D&C RED NO. 40 
D&C YELLOW NO. 6 
GELATIN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
FERRIC OXIDE RED 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (opaque orange body) , BROWN (brown cap) Scoreno score
ShapeCAPSULESize7mm
FlavorImprint Code ZIKS;0203
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63044-203-6110 in 1 BOX, UNIT-DOSE
110 in 1 BLISTER PACK
2NDC:63044-203-01100 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/FEIBusiness Operations
JLM Pharmatech966721805MANUFACTURE

Revised: 12/2009
 
Nnodum Pharmaceuticals

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