Label: FUSION (vitamin c, ferrous fumarate, polysaccharide iron complex, lactobacillus casei- ke-99 capsule

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated December 7, 2015

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    Supplement Facts

    Serving Size: 1 Capsule

    Amount Per Serving%DV*

    % Daily Value

    for Pregnant or

    Lactating Women

    Vitamin C                                                25 mg42%42%
    Iron                                                        130 mg722%722%

       (65 mg from Ferrous Fumarate)

       (65 mg from Polysaccharide Iron Complex)

    Lactobacillus casei (KE-99)                    

    200 Billion CFU/g**

    30 mg

    * Percent daily value based on 2,000 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

    Other Ingredients: Titanium Dioxide, FD&C Blue #1, FD&C Red # 40, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate.
    Patent Numbers: USA:6,797,266; 5,626,883; Mexico MX/a/2008/004461; Singapore: 200802623-9 and other countries.

    INDICATIONS: FusionTM is indicated for the treatment of iron deficiency anemia, which may occur due to an increased need for iron, a deficient intake of iron, or an excessive loss of iron. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together.

    CONTRAINDICATIONS: FusionTM 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 hemolytic anemias.
    Ferrous Fumarate and Polysaccharide Iron Complex: All FusionTM 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 (patented 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).

  • PRECAUTIONS

    PRECAUTIONS: The use of this product by immunocompromised patients or treatment of any disorder must be medically supervised by a physician.

  • DOSAGE & ADMINISTRATION

    OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea, vomiting, and, in severe cases, cardiovascular collapse and death. Other symptoms may include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/Kg body weight. When overdoses are ingested by children, severe reactions including fatalities, have resulted. FusionTM should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this product and all drugs out of reach of children.

    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: FusionTM are Maroon Opaque Vcaps® Plus capsules imprinted "US" logo and " F" in white. Child resistant bottles of 30 capsules, NDC# 52747-501-30. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Vcaps® Plus and the Vcaps® Logo are trademarks used under license.

  • WARNINGS

    Consult package literature for full prescription information. You should contact you 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. Manufactured with Vcaps® Plus capsule shells. Manufactured in a FDA registered facility in the USA.

    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.

  • SAFE HANDLING WARNING

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

  • HEALTH CLAIM

    Iron / Vitamin C / Probiotic Supplement Capsules

  • Packaging

    Fusioncaps

  • INGREDIENTS AND APPEARANCE
    FUSION 
    vitamin c, ferrous fumarate, polysaccharide iron complex, lactobacillus casei (ke-99) capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:52747-501
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID25 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
    IRON POLYMALTOSE (UNII: UM5219H89V) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION65 mg
    LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00) LACTOBACILLUS CASEI30 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:52747-501-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement12/30/2014
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)19 mm
    scoring1
    imprint
    Labeler - US Pharmaceutical Corporation (048318224)
    Establishment
    NameAddressID/FEIBusiness Operations
    Altora Pharma Solutions044404586manufacture(52747-501)