Label: RUBUS- rubus fruticosus, iris germanica, vaccinium myrtillus, syzygium jambolanum, okoubaka aubrevillei liquid

  • NDC Code(s): 60986-1011-3, 60986-1011-4
  • Packager: Marco Pharma International LLC.
  • 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 December 9, 2021

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  • Active Ingredients

    Rubus Fruticosus 2xHPUS

    Iris Germanica 4xHPUS

    Vaccinium Myrtillus 3xHPUS

    Syzygium Jambolanum 3xHPUS

    Okoubaka Aubrevillei 6xHPUS

    The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

    Purpose

    For temporary relief of pancreatic discomforts.

    Keep out of reach of children.

    Suggested use

    Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening.

    Warnings

    If pregnant or breast-feeding, consult a health professional before use. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

    (Read Suggested Use Section)

    Inactive Ingredients

    Ethyl alcohol (52% by vol.) and Water

  • PRINCIPAL DISPLAY PANEL

    Rubus_N1S183_N1L183

  • INGREDIENTS AND APPEARANCE
    RUBUS 
    rubus fruticosus, iris germanica, vaccinium myrtillus, syzygium jambolanum, okoubaka aubrevillei liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60986-1011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACKBERRY (UNII: 8A6OMU3I8L) (BLACKBERRY - UNII:8A6OMU3I8L) BLACKBERRY2 [hp_X]  in 100 mL
    IRIS X GERMANICA ROOT (UNII: 8N6VTJ9IWV) (IRIS X GERMANICA ROOT - UNII:8N6VTJ9IWV) IRIS X GERMANICA ROOT4 [hp_X]  in 100 mL
    BILBERRY (UNII: 9P2U39H18W) (BILBERRY - UNII:9P2U39H18W) BILBERRY3 [hp_X]  in 100 mL
    SYZYGIUM CUMINI SEED (UNII: 820LSF646I) (SYZYGIUM CUMINI SEED - UNII:820LSF646I) SYZYGIUM CUMINI SEED3 [hp_X]  in 100 mL
    OKOUBAKA AUBREVILLEI BARK (UNII: MK2074187Z) (OKOUBAKA AUBREVILLEI BARK - UNII:MK2074187Z) OKOUBAKA AUBREVILLEI BARK6 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60986-1011-350 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/1992
    2NDC:60986-1011-4100 mL in 1 PACKAGE; Type 0: Not a Combination Product03/01/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/1992
    Labeler - Marco Pharma International LLC. (161994277)
    Registrant - Marco Pharma International LLC. (161994277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nestmann Pharma GmbH323426262manufacture(60986-1011)