Label: FERROUS SULFATE- iron supplement therapy tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated December 5, 2017

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  • Supplement Facts

  • Amount per serving

    Iron (as dried ferrous sulfate) 65mg.............360%

  • Directions

    Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician. Children under 12 years of age: consult a physician. Do not chew or crush tablet. Tablets are enteric-coated to  help protect your stomach.

  • Other Ingredients

    Dicalcium phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium stearate, silica, methacrylic acid copolymer, propylene glycol, talc, titanium dioxide, polysorbate, sodium lauryl sulfate, polyvinyl alcohol, FD&C Red #40.

  • Warnings

    Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Iron-containing products may cause constipation or diarrhea. As with any dietary supplement, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

  • BOXED WARNING (What is this?)

    Boxed 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.

  • Storage

    Store in a cool, dry place.

    Protect contents from light and moisture. you may report side effects by calling 1-844-221-7294.

  • Ferrous Sulfate Iron supplement therapy325mg each tablet30 Tablets 

    image description

  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    iron supplement therapy tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69517-133
    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
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-133-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/05/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceuticals078301063manufacture(69517-133)
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Safety

Boxed Warnings, Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

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