Label: IFEREX 150 - iron capsule
- NDC Code(s): 63044-203-01, 63044-203-61
- Packager: Nnodum Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- BOXED WARNING(What is this?)
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.Close
- SPL UNCLASSIFIED SECTION
(Polysaccharide-Iron Complex) Hematinic
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.Close
Iferex 150 is indicated for the prevention and treatment of iron deficiency anemia and / or nutritional megalobastic anemias.Close
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.Close
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.Close
- DOSAGE AND ADMINISTRATION:
Adults - 1 to 2 capsules daily; pediatric patients, as directed by a physician.Close
- 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)Close
- 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).
Cincinnati, Ohio 45229
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
polysaccharide-iron complex capsule
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63044-203 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRON (IRON) IRON 150 mg Inactive Ingredients Ingredient Name Strength 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 Color ORANGE (opaque orange body) , BROWN (brown cap) Score no score Shape CAPSULE Size 7mm Flavor Imprint Code ZIKS;0203 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63044-203-61 10 in 1 BOX, UNIT-DOSE 1 10 in 1 BLISTER PACK 2 NDC:63044-203-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 10/28/2007 Labeler - Nnodum Pharmaceuticals (960457273) Establishment Name Address ID/FEI Business Operations JLM Pharmatech 966721805 MANUFACTURE