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HemeTab

Generic Name: folic acid, cyanocobalamin, iron sucrose, heme iron polypeptide
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

HemeTab (Iron Supplement Tablets)

DESCRIPTION:

Supplement Facts
Serving Size: 1 Tablet

Amount Per Serving
Folic acid
1 mg
Vitamin B12 (cyanocobalamin)
25 mcg
Iron

     (as polysaccharide iron complex)
22 mg
     (as heme iron polypeptide)
6 mg
OTHER INGREDIENTS: microcrystalline cellulose, starch, colloidal silica dioxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, FD&C red no. 40 aluminum lake, FD&C blue no. 2 aluminum lake

INDICATIONS AND USAGE:

HemeTab is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.

CONTRAINDICATIONS:

This product is contraindicated in patients with known hypersensitivity to any of the ingredients. This product is also contraindicated in patients with hemochromatosis and hemosiderosis.

WARNINGS AND PRECAUTIONS:

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.

Folic acid is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this product for pregnant women, nursing mothers, or for women prior to conception, their medical condition and use of other drugs, herbs, and/or supplements should be considered.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237.

DOSAGE AND ADMINISTRATION:

One tablet daily with or without food or as prescribed by a physician.

HOW SUPPLIED:

HemeTab is supplied as a purple tablet, imprinted “510”, in child-resistant bottles of 90 tablets, NDC 76331-900-90. Tamper evident by foil seal under cap.

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).  [See USP controlled room temperature].

Manufactured for:
WH Nutritionals
1000 N. West St., Suite 1200, #894
Wilmington, DE 19801
HemeTab  
folic acid, cyanocobalamin, iron sucrose, heme iron polypeptide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76331-900
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug
IRON SUCROSE (FERRIC CATION) FERRIC CATION 22 mg
HEME IRON POLYPEPTIDE (HEME IRON POLYPEPTIDE) HEME IRON POLYPEPTIDE 6 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
TITANIUM DIOXIDE  
TALC  
FD&C RED NO. 40  
FD&C BLUE NO. 2  
Product Characteristics
Color purple Score no score
Shape CAPSULE (caplet) Size 21mm
Flavor Imprint Code 510
Contains         
Packaging
# Item Code Package Description
1 NDC:76331-900-90 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2012
Labeler - WH Nutritionals, LLC (968642293)
Revised: 10/2012
 
WH Nutritionals, LLC



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