Label: FUSION (vitamin c, ferrous fumarate, polysaccharide iron complex, lactobacillus casei- ke-99 capsule
- NHRIC Code(s): 52747-501-30
- Packager: US Pharmaceutical Corporation
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated December 7, 2015
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STATEMENT OF IDENTITY
Serving Size: 1 Capsule
Amount Per Serving %DV*
% Daily Value
for Pregnant or
Vitamin C 25 mg 42% 42% Iron 130 mg 722% 722%
(65 mg from Ferrous Fumarate)
(65 mg from Polysaccharide Iron Complex)
Lactobacillus casei (KE-99)
200 Billion CFU/g**
* 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).
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.
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
- HEALTH CLAIM
INGREDIENTS AND APPEARANCE
vitamin c, ferrous fumarate, polysaccharide iron complex, lactobacillus casei (ke-99) capsule
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:52747-501 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 25 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 65 mg IRON POLYMALTOSE (UNII: UM5219H89V) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 65 mg LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00) LACTOBACILLUS CASEI 30 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:52747-501-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 12/30/2014 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 19 mm scoring 1 imprint Labeler - US Pharmaceutical Corporation (048318224) Establishment Name Address ID/FEI Business Operations Altora Pharma Solutions 044404586 manufacture(52747-501)