Multigen Caplets by Breckenridge Pharmaceutical
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Statements
Dosage and Administration:
Usual adult dosage is 1 caplet daily, or as directed by a physician or healthcare provider.
Do not use this product if the inner safety seal under the cap is torn, broken or missing.
Allergen: Contains Soy.
Contraindications:
Multigen Caplets are contraindicated in patients with a known hypersensitivity to any of the ingredients. All iron compounds are contraindicated in patients with hemochromatosis and hemosiderosis.
Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Precautions:
General: Do not exceed recommended dosage.
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.
Pediatric use: Safety and effectiveness in the pediatric population have not been established.
Geriatric use:
Clinical studies on this product have not been performed in 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.
Adverse reactions:
Adverse reactions with iron supplementation may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient.
To report a serious adverse event contact: 1-800-367-3395.
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. Protect from light and moisture. Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF.
Sumalate is a registered trademark of Albion Laboratories and is protected under U.S. Patent Nos. 5,516,925; 6,716,814; 8,007,846. Other U.S. patents pending.
2011 Breckenridge Pharmaceutical, Inc. All rights reserved.
Sumalate (Ferrous Asparto Glycinate) is a registered trademark of Albion International, Inc., Clearfield, Utah and is licensed exclusively to Breckenridge Pharmaceutical, Inc., for certain iron products.
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.