Label: FERROUS SULFATE- ferrous sulfate 325 mg red tablet, film coated

  • NHRIC Code(s): 16103-359-08, 16103-359-11
  • Packager: Pharbest Pharmaceuticals, Inc.
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated March 27, 2021

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  • Supplement Facts

    Serving Size 1 Tablet

    Servings Per Container 1000

     Amount Per Serving    % Daily Value
     Iron (as ferrous sulfate) 65 mg361%

    Other ingredients: croscarmellose sodium, dicalcium phosphate, FD&C red #40, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

    Formula: Each tablet contains 202 mg of dried ferrous sulfate USP, equivalent to 325 mg of ferrous sulfate USP (65 mg of elemental iron), equivalent to 325 mg of ferrous sulfate USP.

  • Directions:

    Adults and children over 12 years age: 1 tablet daily preferably with a meal or as directed by a doctor. Children under 12 years of age: consult a doctor. Do not exceed recommended dosage.

  • Caution:

    Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within two hours of each other. If you are pregnant, nursing or taking any medications, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur.

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of overdose, call a doctor or Poison Control Center right immediately.

  • SAFE HANDLING WARNING

    Store at room temperature. Keep tightly closed in a cool dry place.

    Questions or comments? (866) 562-2756 

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    Manufactured in the USA

    *Compare to the active ingredient in Feosol®

    Ferrous 

    Sulfate

    Iron Supplement

    325 mg

    1000 TABLETS

    Ferrous Sulfate 325 mg Tablet Product Label

  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate 325 mg red tablet, film coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:16103-359
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:16103-359-08100 in 1 BOTTLE, PLASTIC
    2NHRIC:16103-359-111000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement07/22/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)10 mm
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture, analysis, pack, label
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