Ferrex 150 Polysaccharide-Iron Complex Capsules are a product of ferric iron complexed to a
low molecular weight polysaccharide.
Suggested/Recommended/Usage/Directions
Indication and Usage
Ferrex 150 may be used for the dietary management of iron deficiencies.
Precautions re: Allergies
Contraindications
Ferrex 150 is contraindicated in patients with a known hypersensitivity to any of the
components of this product.
Precautions re: All Other
Hemochromatosis and hemosiderosis are contraindications in the
use of this dietary supplement.
Precautions re: Allergies
Precautions
This product contains FD&C Yellow No. 5 Lake (Tartrazine) which may cause allergic-type
reactions (including bronchial asthma) in certain susceptible persons. Although the overall
incidence of FD&C Yellow No. 5 Lake (Tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Precautions re: All Other
The type of anemia and the underlying cause or causes should be determined before initiating supplementation with Ferrex 150. Since the anemia may be a result of a systematic disturbance, such as a recurrent blood loss, the underlying cause or causes should be corrected if possible.
Precautions re: Children
As with all oral iron preparations, Ferrex 150 should be stored out of the reach of children to protect against accidental iron poisoning.
Patients should not exceed the recommended dosage unless directed by a physician. Patients should be informed that iron products can cause dark or black stools.
Precautions re: Pregnant or Nursing or Prescription Medications
Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within two hours of each other.
Precautions re: Pregnant or Nursing or Prescription Medications
If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.
Precautions re: Children
Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in 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 re: All Other
Adverse Reactions
Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stool and abdominal pain. Adverse reactions with iron therapy are usually transient.
Precautions re: All Other
Overdosage
The clinical cause of acute iron overdose can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
Suggested/Recommended/Usage/Directions
Dosage and Administration
Usual adult dosage is one or two capsules daily, or as directed by a physician or health-care
provider. Do not exceed recommended dosage.
General Statements: All Other Content
How Supplied
Ferrex 150 Capsules are supplied as orange/brown capsules, imprinted “B203”. Each blister
contains 10 capsules per card, 51991-203-11.
Precautions re: Children
Warning: Keep this and all medications out of the reach of children.
Storage
Store at 25 degrees C (77 degrees F); excursions permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees F). See USP controlled room temperature. Protect from light and moisture.
FDA Statement of Identity
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
General Statements: All Other Content
All substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Precautions re: All Other
To report a serious adverse event contact: 1-800-367-3395.
Warning: Reproductive harm - www.P65Warnings.ca.gov.