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Brawley, CA 92227 
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Novaferrum bottle 4 oz by Gensavis Pharma

Image 0 of Novaferrum bottle 4 oz by Gensavis PharmaImage 1 of Novaferrum bottle 4 oz by Gensavis PharmaImage 2 of Novaferrum bottle 4 oz by Gensavis Pharma

Novaferrum bottle 4 oz by Gensavis Pharma

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Item Profile
Item No.RXD4341715/RXB10092407
NDC No. 52304071204
Generic Name:Iron Polysacc Cmplx/Vit C/Fa
. Trade Name: Novaferrum
Additional Description:Bottle
Strength:
Form Powder for oral suspension
Size 120 ml
Unit of Measure ml
Unit of Sale Each
Unit Dose
Schedule No. 0
Private Label 999
Multi-Source N
Active Status Active
Generic Ind. Branded Drug
Drug Class Rx
Vendor Name Gensavis
Ahfs 200404 - Iron Preparations
Fineline 8500 - UPC No.: 352304712043 Mfg.Item No.

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DESCRIPTION:

Vitamin C - 60 mg

Folic Acid -1,000 mcg

Iron -100 mg


Other Ingredients:
Modified Food Starch, Dextrose*, Sucralose, Raspberry and Grape Flavors, (natural and artificial) *not a significant source of dietary sugars.




CLINICAL PHARMACOLOGY: This product is used as an Iron Supplement to elevate blood levels of iron (e.g., iron deficiency anemia). Iron helps produce red blood cells that carry oxygen throughout the body. NovaFerrum provides 100mg of elemental iron per serving. This product comes in a powder form that dissolves in purified or distilled water.


INDICATIONS: NovaFerrum is indicated for the use in improving the nutritional status for the prevention and treatment of iron deficiency anemia. *


* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.


CONTRAINDICATIONS: NovaFerrum is contraindicated in patients with a known hypersensitivity to any of the compounds of this product. Iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias.


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.



PRECAUTIONS: The type of anemia, and cause, should be determined before proceeding with iron therapy. Folic acid in doses over 0.1 mg daily may obscure pernicious anemia.












ADVERSE REACTIONS: Iron therapy can possibly include constipation, nausea, diarrhea, dark stools, vomiting, and abdominal pain. Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.


PEDIATRIC USE: Safety and effectiveness of this product has not been established in pediatric patients: take as directed by physician.


DOSAGE AND ADMINISTRATION: Adults and children over 12 years of age: 1 tsp. (5ml) daily. Total 24 servings (120 ml) in a bottle. Children under 12 years of age: take as directed by physician.


Strength: Serving Size 1 tsp. (5 ml)



Quantity: 24 servings (120 ml)



HOW SUPPLIED: 4 ounce Bottle

Pharmacist: Add 120ml purified water. Shake well to dissolve.

REFRIGERATE AFTER MIXING WITH WATER.

(Discard 30 days after reconstitution)


NDC: 52304-712-04


Rx only