Label: IMMUNE SUPPORT SYSTEM- penicillium notatum, penicillium frequentans, aconitum napellus, colloidal silver spray

  • 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 6, 2012

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  • ACTIVE INGREDIENT

    Image of bottle label
    label.jpg

    Active ingredients:
    Penicillium notatum 4X
    Penicillium frequentans 4X
    Aconitum napellus 4X
    Colloidal silver 6X

  • PURPOSE

    Indications: For the temporary relief of minor cold and flu symptoms and nasal congestion

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Indications: For temporary relief of minor cold and flu symptoms and nasal congestion.

    Dosage:
    Adult: Two sprays into each nostril 4 times a day for up to 7 days
    Children 2 - 12 years:  1 spray into each nostril 4 times a day for up to 7 days
    Children under 2:  Consult your pediatrician before use

  • WARNINGS

    Do not use if safety seal on bottle is broken. If you are pregnant or nursing, consult your health care practitioner before use.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION


    Dosage:
    Adult: Two sprays into each nostril 4 times a day for up to 7 days
    Children 2 - 12 years:  1 spray into each nostril 4 times a day for up to 7 days
    Children under 2:  Consult your pediatrician before use
  • INACTIVE INGREDIENT

    Inactive ingredients:

    Deionized water

    Aloe barbadensis leaf juice

    Glycerin

    Sodium chloride

    Sodium phosphate

    Benzalkonium chloride

    Disodium EDTA

    Sodium benzoate

    Sodium citrate

  • PRINCIPAL DISPLAY PANEL

    label.jpg
    image of bottle label
    Image of bottle label
  • INGREDIENTS AND APPEARANCE
    IMMUNE SUPPORT SYSTEM  
    penicillium notatum, penicillium frequentans, aconitum napellus, colloidal silver spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54118-5152
    Route of AdministrationNASAL
    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]  in 30 mL
    PENICILLIUM GLABRUM (UNII: 2IN23YUE0I) (PENICILLIUM GLABRUM - UNII:2IN23YUE0I) PENICILLIUM GLABRUM4 [hp_X]  in 30 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]  in 30 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER6 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54118-5152-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/04/2012
    Labeler - ABCO Laboratories, Inc. (029618279)
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