Feosol Caplets (Glaxosmithkline Consumer)

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DESCRIPTION

FEOSOL Caplets contain pure iron micro particles called carbonyl iron. This advanced formula is specially designed to be well absorbed and gentle on the stomach. Each FEOSOL carbonyl iron caplet delivers 45 mg of pure elemental iron, the same amount of elemental iron contained in the 225 mg ferrous sulfate capsule. At equivalent doses, carbonyl iron and ferrous sulfate were shown to be equally efficacious in correcting hemoglobin, hematocrit and serum iron levels in iron-deficient patients ¹ .

SAFETY

According to the American Association of Poison Control Centers, iron containing supplements are the leading cause of pediatric poisoning deaths for children under six in the United States ² . Widely used as a food additive, carbonyl iron must be gastrically solubilized before it can be absorbed, giving it lower toxicity and enhancing its safety versus any of the ferrous salts ³ . As a result, carbonyl iron presents less chance of harm from accidental overdose. In addition, at equivalent doses, carbonyl iron side effects are no greater than those experienced with ferrous sulfate ⁴ .

WARNINGS

Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron containing medication may occasionally cause constipation or diarrhea.

If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

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.

INGREDIENTS

Lactose, Sorbitol, Carbonyl Iron, Hypromellose. Contains 1% or less of the following ingredients: Carnauba Wax, Crospovidone, FD&C Blue #2 Al Lake, FD&C Red #40 Al Lake, FD&C Yellow #6 Al Lake, Magnesium Stearate, Polydextrose, Polyethylene Glycol, Polyethylene Glycol 8000 (Powder), Stearic Acid, Titanium Dioxide, Triacetin.

DIRECTIONS

Adults--one caplet daily or as directed by a physician. Children under 12 years: Consult a physician.

TAMPER-EVIDENT FEATURE

Each caplet is encased in a plastic cell with a foil back; do not use if cell or foil is broken.

REFERENCES

¹ Devasthali SD, Gordeuk VR, Brittenham GM, et al, "Bioavailability of Carbonyl Iron: A randomized, double-blind study." Eur J Haematology, 1991; 46:272-278.

² FDA Consumer; March 1996:7

³ Heubers, JA, Brittenham GM, Csiba E and Finch CA. "Absorption of carbonyl iron." J Lab Clin Med 1986; 108:473-78.

⁴ Devasthali SD, Gordeuk VR, Brittenham GM, et al, "Bioavailability of a Carbonyl Iron: A randomized, double-blind study." Eur J Haematology, 1991; 46:272-278.

Store at room temperature, avoid excessive heat (greater than 100°F) or humidity.

HOW SUPPLIED

Boxes of 30 and 60 caplets in blisters. Also available in single unit packages of 100 caplets intended for institutional use

Also Available: Feosol Tablets.

Comments or Questions? Call Toll-Free 1-800-245-1040 Weekdays.

Glaxosmithkline Consumer Healthcare, L.P.

Moon Township, PA 15108    Made in USA

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