NDC | 52747-417-28 |
Set ID | 56ab8977-cf0f-4ba3-a4c9-2cd6616f0cbd |
Category | DIETARY SUPPLEMENT |
Packager | US Pharmaceutical Corporation |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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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
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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
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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
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INGREDIENTS AND APPEARANCE
FUSION SPRINKLES
vitamin c, ferrous fumarate, polysaccharide iron complex, folic acid, lactobacillus casei (ke-99) powderProduct 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)