Label: FUSION PLUS- iron / folic acid / vitamin / probiotic supplement capsule

  • NDC Code(s): 52747-502-30
  • Packager: US Pharmaceutical Corporation
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated September 30, 2014

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  • STATEMENT OF IDENTITY

    Supplement Facts 
     Serving Size: 1 Capsule
     Amount per Serving  % DV*  % Daily value for Pregnant or lactating woman
     Vitamin C 75 mg 125% 125 %
     Thiamine  2 mg 133% 118 %
    Riboflavin  3 mg 176 % 150 %
    Niacin 10 mg 50 % 50 %
    Vitamin B6 10 mg 500% 400%
    Folic Acid 1250 mg 313 % 156 %
    Vitamin B12 12 mcg 200 % 150 %
    Biotin 300 mcg 100 % 100 %
    Pantothenic acid  6 mg 60% 60%

    Iron

    (65 mg from Ferrous Fumarate)

    (65 mg from Polysaccharide Iron Complex)

    130 mg 722 % 722 %

    Lactobacillus casei KE-99 

    200 Billion CFU/g**

    30 mg  †  † 

     *Percent Daily Value based on 2000 calorie intake for adults and children 12 years and older. 

    † Daily value not established
     **Colony Forming Units per gram (CFU/g) at time of manufacturing

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  • STATEMENT OF IDENTITY

    INDICATIONS  : Fusion Plus TM is indicated for the treatment of Iron defficiency anemia and folate defficiency as in extended convalescence ,menorrhagia, pregnancy, puberty, excessive blood loss and advanced age.  Also for treatment of condition in which Iron defficiency and Vitamine C defficiency occur together along with a defficient intake or increased need for B-complex vitamins in chronic and acute illness as well as  cases of metabolic stress and convalescence 

    CONTRADICTIONS: Fusion Plus TM is contraindicated in patients with a known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or haemolytic anemias. It is also contradicated in patients suffering from pernicious anemia as folic acid may obscure its signs and symptoms.

    Ferrous Fumarate and Polysaccharide Iron Complex (PIC): All Fusion Plus TM products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No. 11/243,043 Pending). “An increase in tolerability is observed with the (patended formulation) and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient’s blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism”.
    Clinical Studies: Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias: PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No.3. pp.213-220 (July-September 1982).


    Folic Acid: Folic acid is one of the important hematopoietic agents necessary for proper regeneration of the blood-forming elements and their function. Additionally, folic acid increases jejuna glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia.

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  • WARNINGS

    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.

    WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

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  • PRECAUTIONS

    PRECAUTIONS: Folic acid in doses above 0.1 mg – 0.4 mg daily may obscure  pernicious anemia, in that haematological remission can occur while neurological manifestations remain progressive. The use of this product by immunocompromised patients or treatment of any disorder must be medically supervised by a physician

    Consult package literature for full prescription information. You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036. Marketed by US Pharmaceutical Corporation

    CAUTION: Rx only.

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  • SAFE HANDLING WARNING

    Store at controlled room temperature 15°C to 30°C (59° to 86° F). Keep in cool, dry place. 

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

    HOW SUPPLIED: Fusion Plus TM are Pearl Red opaque Vcaps® capsules imprinted “US” logo and “F Plus” in white. Child resistant bottles of 30 capsules, NDC# 52747-502-30. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

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  • HEALTH CLAIM

    Iron / Folic acid / Vitamin / Probiotic Supplement Capsules

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    FUSION PLUS 
    iron / folic acid / vitamin / probiotic supplement capsule
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:52747-502
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 75 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 10 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.25 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 0.012 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 0.3 mg
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 6 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 130 mg
    LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00) LACTOBACILLUS CASEI 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:52747-502-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    dietary supplement 02/01/2013
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    shape
    size (solid drugs) 22 mm
    scoring 1
    imprint
    Labeler - US Pharmaceutical Corporation (048318224)
    Establishment
    Name Address ID/FEI Business Operations
    ABS Corporation 048022727 manufacture(52747-502)
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