FUSION SPRINKLES (vitamin c, ferrous fumarate, polysaccharide iron complex, folic acid, lactobacillus casei- ke-99 powder

FUSION Sprinkles by

Drug Labeling and Warnings

FUSION Sprinkles by is a Other medication manufactured, distributed, or labeled by US Pharmaceutical Corporation, Altora Pharma Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts Serving Size: 1 Packet (3 Grams)
		% Daily Value
Amount Per Serving		Children 1-3 Years	Adults & Children 4 Years & Older***
Vitamin C (Ascorbic Acid)	50 mg	333%	83%
Iron	7 mg	100%	39%
3.5 mg from Ferrous Fumarate    3.5 mg from Polysaccharide Iron Complex
Folic Acid	250 mcg	167%	63%
Lactobacillus casei (KE-99)              200 Billion CFU/g**	5 mg	*	*
* Daily value not established; ** Colony Forming Units per gram (CFU/g) at time of manufacturing; *** % Daily Value based on 2000 calorie intake for adults and children 4 years and older.

Other Ingredients: Maltodextrin. May contain traces of milk and soy.

INDICATIONS

Fusion Sprinkles is indicated for the treatment and prevention of iron deficiency anemia and folate deficiency in children and adults, who are unable to take oral pills. It is formulated with Vitamin C that aids in the absorption of Iron and probiotic, Lactobacillus casei KE-99 that enhances the absorption of nutrients necessary to regain a healthy immune system.
Iron is a mineral that is an essential component of hemoglobin, an erythrocyte protein that transfers oxygen from the lungs to the tissues. Iron is necessary for growth, development, normal cellular functioning, and synthesis of some hormones and connective tissues.
Vitamin C promotes growth and repair of tissues in all parts of your body. It strongly enhances the non-heme iron absorption. It is one of the antioxidants that block the damage caused by free radicals.
Folic Acid is a B vitamin that helps the body to make healthy new cells. It is needed for proper brain function and plays an important role in mental and emotional health. It is necessary for proper regeneration of the blood-forming elements and their function. A deficiency in folic acid may lead to megaloblastic anemia.
Lactobacillus casei KE-99 is a probiotic that enhances nutrient absorption, fight harmful bacteria and boosts the immune system. It reduces digestive discomfort.

WARNING

Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Doses of above 0.1 mg - 0.4 mg daily may obscure the signs and symptoms of pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

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. 

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. Manufactured in an FDA registered facility in the USA.

PRECAUTIONS

The use of this product by immunocompromised patients or taking other medications to treat any medical disorder must be medically supervised by a physician.

RECOMMENDED DOSES

Children 1-3 years of age:
1 packet of 3 grams a day
Adults and Children 4 years and older:
up to 4 packets of 3 grams a day
Do not exceed recommended dosage. Due to high Folic Acid content, proper dosage based on health condition and age group should be determined and medically supervised by a physician.

DIRECTION FOR USE
Empty contents of packet/s into cold food (i.e. applesauce, yogurt, etc.) or drink (i.e. water, juice, etc.) and mix well. Do not add to warm or hot food or to carbonated or alcohol-containing beverages. Prepare only as needed and for immediate administration within thirty (30) minutes. Fusion Sprinkles can be taken with or without food. It can be taken alone or with other dietary supplements.

HOW SUPPLIED

Each packet of Fusion SprinklesTM contains an off-white powder with bits of dark brown particles. Store unopened packets in a cool, dry place, and at room temperature between 15°C to 30°C (59°F - 86°F).

CAUTION
Rx only.  

HEALTH CLAIM

Iron / Vitamin C / Folic Acid / Probiotic Supplement

• Easy to swallow, pleasant tasting sprinkles in a convenient packet
• Can be mixed with cold foods or drinks
• Dual Action Iron combination that repletes both stored and circulating iron levels
• Polysaccharide Iron Complex / Ferrous Fumarate combination for increased iron toleration
• Lactobacillus Probiotic KE-99 for enhanced immune system
• Vitamin C absorption promoter

Packaging

INGREDIENTS AND APPEARANCE

FUSION SPRINKLES 
vitamin c, ferrous fumarate, polysaccharide iron complex, folic acid, lactobacillus casei (ke-99) powder

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:52747-417
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	50 mg  in 3 g
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	3.5 mg  in 3 g
IRON POLYMALTOSE (UNII: UM5219H89V) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	3.5 mg  in 3 g
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	250 ug  in 3 g
LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00)	LACTOBACILLUS CASEI	5 mg  in 3 g

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:52747-417-28	28 in 1 CARTON
1		3 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		11/30/2015

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color

Labeler - US Pharmaceutical Corporation (048318224)

Establishment
Name	Address	ID/FEI	Business Operations
Altora Pharma Solutions		044404586	manufacture(52747-417)