Multigen Plus Multigen Folic Caplets - bpirx.com

1 Sumalate is a registered trademark of Albion Laboratories and is protected under Patent Nos. 5,516,925; 6,716,814; 8,007,846. Other patents pending. 2011 Breckenridge Pharmaceutical, Inc. All rights more information on these products or to take advantageof our sampling program, give us a call or visit us at , Multigen PlusandMultigen Folic CapletsBreckenridgePharmaceutical, Raton, FL (800) 367-3395 Fax (866) 372-7479email: Product Information on back for more information regarding Medical FACTS ABOUT Multigen , Multigen PLUS AND Multigen Folic CAPLETSM ultigen , Multigen Plus and Multigen Folic contain the same active ingredients as Chromagen , Chromagen Forte and Chromagen FA Tablets, formerlymarketed by Ther-Rx Corporation.

2 Sumalate is a unique patent-protected iron formulation of Ferrous Asparto Glycinate. Sumalate is a registered trademark ofAlbion Laboratories and is protected under Patent Nos. 5,516,925; 6,716,814; 8,007,846. Other patents PlusCaplets51991-546-90 Multigen FolicCaplets90 Beige, film-coated caplet,debossed B546 Vitamin CAscorbic Acid (as Calcium Ascorbate) ..150 mgThreonic Acid (as Calcium Threonate) ..2 mgFolic Acid, USP..1 mgVitamin B12(Cyanocobalamin) ..10 mcgElemental Iron (as Sumalate ) ..70 mgSuccinic Acid ..75 mg90 Brown, film-coatedcaplet, debossed B544 Vitamin C Ascorbic Acid (as Calcium Ascorbate).

3 60 mg Threonic Acid (as Calcium Threonate).. mgFolic Acid, USP ..1 mgVitamin B12(as Cyanocobalamin) ..10 mcgElemental Iron (as *Sumalate ) ..50 mgElemental Iron (as Ferrous Fumarate) ..101 mgSuccinic mg51991-543-90 Multigen Caplets90 Beige, film-coatedcaplet, debossed B543 Vitamin C Ascorbic Acid (as Calcium Ascorbate) ..150 mgThreonic Acid (as Calcium Threonate) ..2 mgVitamin B12(as Cyanocobalamin) ..10 mcgElemental Iron (as Sumalate *) ..70 mgSuccinic mgDesiccated Stomach Substance ..50 mgBRECKENRIDGE PRODUCTPRODUCTNUMBERDETAILEDDESCRIPTIONE ACH CAPLET CONTAINSEach Multigen Folic Caplet contains:Vitamin CAscorbic Acid (as Calcium Ascorbate).

4 150 mgThreonic Acid (as Calcium Threonate) ..2 mgFolic Acid, USP..1 mgVitamin B12(Cyanocobalamin) .. 10 mcgElemental Iron (as Sumalate ) .. 70 mgSuccinic Acid .. 75 mgOther ingredients: Microcrystalline Cellulose, Dicalcium Phosphate,Croscarmellose Sodium, Hypromellose, Stearic Acid, Crospovidone, TitaniumDioxide, Magnesium Silicate, Sodium Lauryl Sulfate, Silica, Triacetin,Magnesium Stearate, Polyvinylpyrrolidone, Mineral Oil, FD&C Yellow No. 5 Lake* and FD&C Yellow No. 6 Lake**.*Contains FD&C Yellow No. 5 Lake (Tartrazine) as a color additive (see PRECAUTIONS).

5 ** Contains FD&C Yellow No. 6 Lake as a color additive. Sumalate (Ferrous Asparto Glycinate) is a registered trademark of AlbionInternational, Inc., Clearfield, Utah and is licensed exclusively toBreckenridge Pharmaceutical, Inc., for certain iron AND USAGE:For the dietary management of individuals with distinct nutritional needs ofanemias responsive to oral iron supplementation, such as hypochromicanemia associated with pregnancy, chronic or acute blood loss, dietaryrestriction, metabolic disease and post-surgical convalescence. Multigen Folic is labeled as a medical food intended for use under the active andongoing medical supervision requiring medical care on a recurring basis for,among other things, instructions on the use of the medical Foods.

6 Medical Foods are intended for the dietary management of a patient who,because of therapeutic or chronic medical needs, has limited or impairedcapacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certainnutrients, or who has other special medically determined nutrientrequirements, the dietary management of which cannot be achieved by themodification of the normal diet alone. Although a medical-food product isintended for use under the active and ongoing medical supervision, FDA doesnot require a statements have not been evaluated by the Food and DrugAdministration.

7 This product is not intended to diagnose, treat,cure, or prevent any disease. CONTRAINDICATIONS:This product is contraindicated in patients with a known hypersensitivity toany of the ingredients. All iron compounds are contraindicated in patientswith hemochromatosis and : Accidental overdose of iron-containing products is aleading cause of fatal poisoning in children under 6. Keep thisproduct out of the reach of children. In case of accidental overdose,call a doctor or poison control center Acid alone is improper therapy in the treatment of pernicious anemiaand other megaloblastic anemias where vitamin B12is : Do not exceed recommended product contains FD&C Yellow No.

8 5 (tartrazine) which may causeallergic-type reactions (including bronchial asthma) in certain susceptiblepersons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine)sensitivity in the general population is low, it is frequently seen in patientswho also have aspirin Acid in doses above mg daily may obscure pernicious anemia in thathematologic remission can occur while neurological manifestations remainprogressive. Pernicious anemia should be excluded before using this productsince Folic acid may mask the symptoms of pernicious pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider beforeusing or continuing Use: Safety and effectiveness in the pediatric population, have notbeen Use: Clinical studies on this product have not been performed insubjects aged 65 and over to determine whether elderly subjects responddifferently from younger subjects.

9 In general, dose selection for an elderlypatient should be cautious, usually starting at the low end of the dosingrange, reflecting the greater frequency of decreased hepatic, renal, or cardiacfunction, and of concomitant disease or other drug REACTIONS:Adverse reactions with iron supplementation may include constipation,diarrhea, nausea, vomiting, dark stools and abdominal pain. Adversereactions with iron supplementation are usually sensitization has been reported following both oral and parenteraladministration of Folic AND ADMINISTRATION:Usual adult dosage is 1 caplet daily, or as directed by a physician or health-care SUPPLIEDM ultigen Folic Caplets are available as a beige, film-coated caplet debossed B 546.

10 Supplied in bottles of 90 Caplets , at 25 C (77 F); excursions permitted to 15 -30 C (59 -86 F). See USPC ontrolled Room Temperature. Protect from light and moisture. Dispense ina tight, light-resistant container with a child-resistant closure as defined in not use this product if the inner safety seal under the cap is torn, brokenor : KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH FoodTo report a serious adverse event contact: by:Contract Pharmacal , NY 11788 USAD istributed by:Breckenridge Pharmaceutical, Raton, FL 33487 Patent Nos. 5,516,925; 6,716,814; 8,007, patents 6/11 Multigen CapletsMedical FoodEach Multigen Caplet contains: Vitamin C Ascorbic Acid (as Calcium Ascorbate).