Label: POLYSACCHARIDE-IRON capsule

  • Category: HUMAN OTC DRUG LABEL

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 23, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

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

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!