NovaFerrum

Generic Name: polysacchride iron vitamin mineral complex

Dosage Form: oral powder, for solution
prescribing information

DESCRIPTION:

Vitamin C - 60 mg

Folic Acid -1000 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.

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.

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


REFRIGERATE AFTER MIXING WITH WATER.

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 intended for the use in improving the nutritional status for the prevention and treatment of iron deficiency anemia.

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 1mg 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.

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.

DOSAGE FORMS and STRENGTHS:


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)

NovaFerrum  polysacchride iron vitamin mineral complex   powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52304-712 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRON (IRON) IRON 100 mg  in 5 mL FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg  in 5 mL ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength SUCRALOSE   DEXTROSE   STARCH, CORN

Product Characteristics Color red (dark red powder ) Score      Shape Size Flavor RASPBERRY (Raspberry Flavor) , GRAPE (Grape Flavor) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52304-712-04 120 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/15/2010

Labeler - Gensavis Pharmaceuticals, LLC (961905879)

Registrant - Gensavis Pharmaceuticals, LLC (961905879)

Revised: 04/2010Gensavis Pharmaceuticals, LLC

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