Label: HEMETAB- folic acid, cyanocobalamin, iron sucrose, heme iron polypeptide tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated December 3, 2020

If you are a consumer or patient please visit this version.

  • DESCRIPTION:

    Supplement Facts

    Serving Size: 1 Tablet

    Amount Per Serving
    Folic acid
    1 mg
    Vitamin B 12 (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

  • PRINCIPAL DISPLAY PANEL

    label
  • INGREDIENTS AND APPEARANCE
    HEMETAB 
    folic acid, cyanocobalamin, iron sucrose, heme iron polypeptide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76331-900
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN25 ug
    IRON SUCROSE (UNII: FZ7NYF5N8L) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION22 mg
    HEME IRON POLYPEPTIDE (UNII: 31VDO12CJY) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULE (caplet) Size21mm
    FlavorImprint Code 510
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76331-900-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2012
    Labeler - WH Nutritionals, LLC (968642293)