Ferrex-150

Precautions re: All Other

Contains FD&C Yellow No. 5 Lake (Tartrazine) as a color additive.

Formula re: Contains

Ferrex 150 Polysaccharide-Iron complex capsules are a product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is a product of extensive hydrolysis of starch.

Brand IP Statement(s) re: (c), (TM), (SM)

Ferrex 150 is a dark brown powder that forms a very dark brown solution when dissolved in water.

General Statements: All Other Content

It is tasteless and odorless.

Formulation re: Does NOT Contain

As an organic complex, it contains no free irons.

General Statements: All Other Content

Indications and usage: Ferrex 150 may be used for the dietary management of iron deficiencies.

Precautions re: All Other

Contraindications: Ferrex 150 is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications in the use of this dietary supplement.

Formula re: Contains

Precautions: This product contains FD&C Yellow No. 5 Lake (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

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.

Precautions re: Pregnant or Nursing or Prescription Medications

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

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: Children

As with all oral iron preparations, Ferrex 150 should be stored out of the reach of children to protect against accidental iron poisoning.

Precautions re: All Other

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.

General: Product/Version Code

Re-Order No. 081119 M-29 Rev. 09/11

Formula re: Contains

Polysaccharide-Iron Complex Capsules

FDA Statement of Identity

Dietary Supplement

General Statements: All Other Content

For dispensing purpose only

Precautions re: All Other

Do not use if blister seals are broken

General Statements: All Other Content

10 x 10 Capsules

Precautions re: All Other

To Report Serious Adverse Effects Call: 800-616-2471

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. Overdose: 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, hyperglycemic, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

Suggested/Recommended/Usage/Directions

Dosage and administration: Adults: One or two capsules daily, or as prescribed by a physician.

General Statements: All Other Content

How supplied: Unit Dose blister packs, 10 capsules per card, orange/brown capsules imprinted B-203.

Precautions re: Children

Keep this and all medications out of the reach of children.

Storage

Store at 25(0)C (77(0)F); excursions permitted to 15(0)-30(0)C (59(0)-86(0)F). See USP Controlled Room Temperature.

FDA Disclaimer Statement

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

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