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

Fusion Plus by

Drug Labeling and Warnings

Fusion Plus by is a Other medication manufactured, distributed, or labeled by U.S. Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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.

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.

SAFE HANDLING WARNING

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

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

Iron / Folic acid / Vitamin / Probiotic Supplement Capsules

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)