FUSION- vitamin c, ferrous fumarate, polysaccharide iron complex, lactobacillus casei (ke-99) capsule 
US Pharmaceutical Corporation

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FUSIONTM

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

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.

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.

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

Iron / Vitamin C / Probiotic Supplement Capsules

Packaging

Fusioncaps

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)

Revised: 12/2015
Document Id: afecf74b-a81e-42b5-bba7-f5450e439be9
Set id: 216b32ae-335d-406e-a243-88aa6697a398
Version: 1
Effective Time: 20151207
 
US Pharmaceutical Corporation