Label: NOTATUM- penicillium chrysogenum var. chrysogenum suppository

  • 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 July 22, 2016

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  • Indications

    For temporary relief of minor cold symptoms, fever, earaches, and respiratory infections.

  • Ingredients

    182 mg Penicillium notatum (chrysogenum) 3X in a base of mono-, di-, triglycerides (hard fat).

  • Dosage

    Insert one suppository rectally each night before bed.

  • Warning

    If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

    Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Protect from light and heat.

  • Tamper Evident

    Use this product only if inner blister pack is intact.

  • QUESTIONS

    To report adverse events, contact BioResource at 707/664-9023 or bioresource@prodigy.net

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    BioResource Inc.
    Cotati, CA 94931

  • PRINCIPAL DISPLAY PANEL - 10 Suppository Blister Pack Box

    SanPharma™
    Notatum
    Suppositories 3X

    Homeopathic
    Medicine

    For minor cold symptoms.

    10 SUPPOSITORIES
    SanPharma™

    PRINCIPAL DISPLAY PANEL - 10 Suppository Blister Pack Box
  • INGREDIENTS AND APPEARANCE
    NOTATUM 
    penicillium chrysogenum var. chrysogenum suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54256-039
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    FAT, HARD (UNII: 8334LX7S21)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54256-039-041 in 1 BOX01/01/2001
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic01/01/2001
    Labeler - BioResource Inc. (017532917)
    Establishment
    NameAddressID/FEIBusiness Operations
    RubiePharm Arzneimittel GmbH313767774MANUFACTURE(54256-039)
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