IFEREX 150- polysaccharide-iron complex capsule

IFEREX 150 by

Drug Labeling and Warnings

IFEREX 150 by is a Other medication manufactured, distributed, or labeled by Nnodum Pharmaceuticals, Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Statement of identity

iFEREX 150 is an easily assimilated source of iron for treatment of uncomplicated iron deficiency anemia.

Healthn Claims

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

Warning

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

Dosage and Administration

Adults: One or two capsules daily or as directed by a physician.

Precautions

General: The type of anemia and underlying cause or causes should be determined before starting therapy with iFerex 150. Since the

anemia may be a result of systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

Safe Handling Warning

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER WITH A RESISTANT CLOSURE.

STORAGE: Store at 20oC-25​oC (68​o- 77oF); excursions to 15oC-30oC (59o-86oF)

Principal Display Panel - IFEREX 150

ZIKs  63044-0203-01

iFEREX 150

Polysaccharide Iron

Complex Hematinic

100 Capsules

EACH CAPSULE CONTAINS:

Iron (elemental).....................150 mg

 (polysaccharide iron complex 326.1 mg)

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

DESCRIPTION: iFerex 150 is a brown and orange capsule with marking "ziks 0203".

It is a product of ferric iron complexed to a low molecular weight polysaccharide.

INDICATIONS AND USAGE: iFerex 150 is indicated for the prevention and treatment of

iron deficiency anemia and/or nutritional megaloblastic anemias.

CONTRAINDICATIONS: iFerex 150 is indicated in patients with a known hypersensitivity

to any of the components of this product. Hemochromatosis and hemosiderosis are

contraindications to iron therapy.

ADVERSE REACTIONS: Adverse reactions with iron therapy may include constipation,

diarrhea, nausea, vomiting, dark stools, and abdomibal pain. Adverse reactions with iron

tharapy are usually transient.

WARNING: Accidental overdose of iron-containing products is a leading cause in

fatal poisoning of 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: The type of anemia and underlying cause or causes

should be determined before starting therapy with iFerex 150.  Since the

anemia may be a result of systemic disturbance, such as recurrent blood loss,

the underlying cause or causes should be corrected, if possible.

DOSAGE AND ADMINISTRATION: Adults: One or two capsules daily or as directed by a physician.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

​DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER WITH A RESISTANT CLOSURE.

STORAGE: Store at 20​o​C-25​o​C (68​o​- 77​​o​F); excursions to 15​o​C-30​o​C (59​o-86​o​F)

HOW SUPPLIED: iFerex 150 capsules are supplied in 100 capsule per bottle.

Distributed by Nnodum Pharmaceuticals, Cincinnati, OH 45229

NP 6/18/09

LC-10872

3 63044 20301 2

INGREDIENTS AND APPEARANCE

IFEREX 150 
polysaccharide-iron complex capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:63044-203
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	150 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:63044-203-61	10 in 1 BOX, UNIT-DOSE
1		10 in 1 BLISTER PACK
2	NHRIC:63044-203-01	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		03/01/2018

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
color
imprint
shape
size (solid drugs)	7 mm
scoring	1

Labeler - Nnodum Pharmaceuticals (960457273)

Establishment
Name	Address	ID/FEI	Business Operations
PD Pharmatech, LLC.		063753431	manufacture