Label: NOTATUM- penicillium chrysogenum var. chrysogenum liquid

  • 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 January 25, 2016

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  • PURPOSE

    Indications

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

  • Dosage

    5–10 drops, three times daily.

  • ACTIVE INGREDIENT

    Ingredients

    10 ml Penicillium notatum (chrysogenum) 4X in a base of purified water, 0.09 g sodium chloride, 0.01 g potassium sorbate.

  • Warning

    If symptoms persist, contact a licensed practitioner.

    If you are pregnant or nursing, seek advice of a health care professional before use.

    Keep out of 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

    Do not use product if tamper evident strip is broken or removed from base of cap. To report adverse events, contact BioResource at 707/664-9023 or bioresource@bioresourceinc.com

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    BioResource Inc.
    Cotati, CA 94931

  • PRINCIPAL DISPLAY PANEL - 10 ml Bottle Label

    SanPharma™ Notatum Drops 4X

    Homeopathic Medicine • 0.34 FL OZ (10 ml)

    SanPharma™

    Principal Display Panel - 10 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    NOTATUM 
    penicillium chrysogenum var. chrysogenum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54256-040
    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]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium chloride (UNII: 451W47IQ8X)  
    Potassium sorbate (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54256-040-031 in 1 BOX
    110 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/01/2016
    Labeler - BioResource Inc. (017532917)
    Establishment
    NameAddressID/FEIBusiness Operations
    RubiePharm Arzneimittel GmbH313767774MANUFACTURE(54256-040)
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