Label: IMMUNE SUPPORT SYSTEM- penicillium notatum, penicillium frequentans, aconitum napellus, ferrum phosphoricum tablet

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 19, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Penicillium Notatum 4X

    Penicillium Frequentans 4X

    Aconitum Napellus 4X

    Ferrum Phosphoricum 6X

  • PURPOSE


    For the relief of minor cold and flu symptoms
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.


  • INDICATIONS & USAGE

    Indications:

    for the relief of minor cold and flu symptoms.

    Dosage:

    Adults and children age 2 and older: allow one tablet to dissolve in mouth four times a day.

    Children 2-4 years: crush one tablet and mix into a small amount of soft food, such as apple sauce, four times a day. use only under parental supervision.

    Children under 2 years: consult your health care practitioner before use.


  • WARNINGS

    Do not use if safety seal on bottle is broken.

    store in a cool, dry place.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Lactose, magnesium stearate

  • DOSAGE & ADMINISTRATION

    Adults and children age 2 and older: allow one tablet to dissolve in mouth four times a day.

    Children 2-4 years: crush one tablet and mix into a small amount of soft food, such as apple sauce, four times a day. use only under parental supervision.

    Children under 2 years: consult your health care practitioner before use.
  • PRINCIPAL DISPLAY PANEL

    image of bottle label


    Image of bottle label
    label.JPEG
  • INGREDIENTS AND APPEARANCE
    IMMUNE SUPPORT SYSTEM  
    penicillium notatum, penicillium frequentans, aconitum napellus, ferrum phosphoricum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54118-7199
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM4 [hp_X]
    PENICILLIUM GLABRUM (UNII: 2IN23YUE0I) (PENICILLIUM GLABRUM - UNII:2IN23YUE0I) PENICILLIUM GLABRUM6 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (uncoated tablet) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54118-7199-130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/01/2012
    Labeler - ABCO Laboratories, Inc. (029618279)