Polysaccharide-Iron Complex

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Hard stools (constipation).
• Change in color of stool to green.
• Loose stools (diarrhea).
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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• Iron-Polysaccharide Complex
• Niferex

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

EZFE 200: 200 mg [non-toxic; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Ferrex 150: 150 mg [contains fd&c blue #1 aluminum lake, fd&c red #40 aluminum lake, fd&c yellow #5 aluminum lake]

Ferric x-150: 150 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, tartrazine (fd&c yellow #5)]

FerUS: 150 mg [DSC]

iFerex 150: 150 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Myferon 150: 150 mg

NovaFerrum 50: 50 mg

Nu-Iron: 150 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]

PIC 200: 200 mg

Poly-Iron 150: 150 mg

Liquid, Oral:

NovaFerrum 125: Polysaccharide-iron complex 125 mg and cholecalciferol 100 units per 5 mL (180 mL) [alcohol free, dye free, gluten free, lactose free, sodium free, sugar free; contains sodium benzoate; raspberry-grape flavor]

NovaFerrum Pediatric Drops: 15 mg/mL (120 mL) [alcohol free, dye free, gluten free, lactose free, sodium free, sugar free; contains sodium benzoate; raspberry-grape flavor]

• Iron Salt

Absorption

Oral: Iron is absorbed in the duodenum and upper jejunum; in persons with normal iron stores 10% of an oral dose is absorbed; this is increased to 20% to 30% in persons with inadequate iron stores; food and achlorhydria will decrease absorption

Excretion

Urine, sweat, sloughing of intestinal mucosa, and by menses

Known hypersensitivity to polysaccharide-iron complex or any component of the formulations; hemochromatosis; hemosiderosis

Documentation of allergenic cross-reactivity for other iron-containing products is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Refer to adult dosing.

Store between 15°C and 30°C (59°F and 86°F).