Label: FUSION PLUS- iron / folic acid / vitamin / probiotic supplement capsule
- NHRIC Code(s): 52747-502-30
- Packager: US Pharmaceutical Corporation
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
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%
(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
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.
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.
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.
- SAFE HANDLING WARNING
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.
- HEALTH CLAIM
INGREDIENTS AND APPEARANCE
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)