Label: POLYSACCHARIDE-IRON capsule

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

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Drug Label Information

Updated December 23, 2019

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  • Drug Facts

    .

  • Active Ingredient

    (in each capsule)

    Iron (as Polysaccharide Iron) 150 mg

  • Purpose

    Iron Supplement

  • Uses

    • Iron Supplement
  • WARNINGS

    Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause black stools, constipation or diarrhea. If pregnant or breast feeding, ask a health professional before use.

    Accidental overdose of Iron containing products is a leading cause of fatal poisoning in children under 6.

    DRUG INTERACTION PRECAUSION: Since oral iron products interfere with absorption of tetracycline antibiotics, these products should not be taken within two hours of each other.

  • Keep out of reach of children.

    In case of accidental overdose, call a doctor or poison control center immediately.

  • Directions

    Adults only: One capsule daily or as directed by a doctor. Do not exceed recommended dosage.

  • Other Information

    • store at 15-30 °C (59-86 °F). Do not expose to excessive heat or moisture.
  • Inactive Ingredients

    Microcrystalline Cellulose, geltain, corscarmellose sodium, citric acid anhydrous, stearic acid, titanium dioxide, D&C Yellow #10, sodium lauryl sulfate, FD&C Yellow #6, FD&C Red#40, FD&C Blue #1and white ink

  • Questions or Comments

    TAMPER RESISTENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    e71c431d-figure-01

    NDC

  • INGREDIENTS AND APPEARANCE
    POLYSACCHARIDE-IRON 
    polysaccharide-iron capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-077
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON150 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    GELATIN (UNII: 2G86QN327L)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColororangeScorescore with uneven pieces
    ShapeCAPSULESize19mm
    FlavorImprint Code 077
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-077-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/26/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/26/2015
    Labeler - Advance Pharmaceutical Inc. (078301063)
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