FUSION SPRINKLES (VITAMIN C, FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX, FOLIC ACID, LACTOBACILLUS CASEI (KE-99)) POWDER [US PHARMACEUTICAL CORPORATION]

FUSION SPRINKLES (VITAMIN C, FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX, FOLIC ACID, LACTOBACILLUS CASEI (KE-99)) POWDER [US PHARMACEUTICAL CORPORATION]
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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
  • 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 mg333%83%
    Iron                                                    7 mg100%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

    fusionsprin1

  • INGREDIENTS AND APPEARANCE
    FUSION SPRINKLES 
    vitamin c, ferrous fumarate, polysaccharide iron complex, folic acid, lactobacillus casei (ke-99) powder
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:52747-417
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID50 mg  in 3 g
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION3.5 mg  in 3 g
    IRON POLYMALTOSE (UNII: UM5219H89V) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION3.5 mg  in 3 g
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID250 ug  in 3 g
    LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00) LACTOBACILLUS CASEI5 mg  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:52747-417-2828 in 1 CARTON
    13 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement11/30/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    Labeler - US Pharmaceutical Corporation (048318224)
    Establishment
    NameAddressID/FEIBusiness Operations
    Altora Pharma Solutions044404586manufacture(52747-417)