Multigen Caplets

51991-543-60

Do not use this product if the inner safety seal under the cap is torn, broken or missing.

Detailed description Beige, film-coated caplet, debossed B543

Important facts about Multigen, Multigen Plus and Multigen Folic Caplets Multigen, Multigen Plus and Multigen Folic contain the same active ingredients as Chromagen, Chromagen Forte and Chromagen FA Tablets, formerly marketed by Ther-Rx Corporation.

Sumalate is a unique patent-protected iron formulation of Ferrous Asparto Glycinate.

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.

See product information on back for more information regarding Medical Foods. For more information on these products or to take advantage or our sampling program, give us a call or visit us at www.bpirx.com.

2011 Breckenridge Pharmaceutical, Inc. All rights reserved.

Allergen: Contains Soy.

Allergen: Contains Soy.

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.

Indications and usage: For the dietary management of individuals with distinct nutritional needs for anemias responsive to oral iron supplementation, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post surgical convalescence. Multigen is labeled as a medical food intended for use under the active and ongoing medical supervision requiring medical care on a recurring basis for, among other things, instructions on the use of the medical food.

Medical foods: Medical Foods are intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone. Although a medical-food product is intended for use under the active and ongoing medical supervision, FDA does not require a prescription.

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.

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.

Dosage and Administration: Usual adult dosage is 1 caplet daily, or as directed by a physician or healthcare provider.

How supplied: Multigen Caplets are available as a film-coated beige, capsule-shaped tablet, debossed “B543”. Supplied in bottles of 90 caplets, 51991-543-90.

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.

Do not use this product if the inner safety seal under the cap is torn, broken or missing.

Medical food

To report a serious adverse event contact: 1-800-367-3395.