Label: DIGESTION RELIEF- dolichos pruriens, lycopodium clavatum, leptandra virginica, carduus marianus, chelidonium majus, boldo pellet

  • 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 November 5, 2013

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  • ACTIVE INGREDIENTS HPUS

    Dolichos pruriens 3X

    Lycopodium clavatum 3X

    Leptandra virginica 3X

    Carduus marianus 3X

    Chelidonium majus 1X

    Boldo 1X

  • REFERENCES

    Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

  • PURPOSE

    Helps relief digestive discomfort

  • USES

    This Homeopathic product of natural source helps relieve digestive discomfort, nausea, bloating and gas.

  • WARNINGS

  • ASK DOCTOR

    If symptoms persist or worsen, discontinue use and contact a health professional.

  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications out of reach of children.

  • DIRECTIONS

    Adults: Allow 3 pellets to dissolve under the tongue three times a day or as directed by a health professional.

    Children under 12: Take 1/2 the adult dosage. Do not exceed recommended dosage.

  • OTHER INFORMATION

    Do not use if cap seal is broken.

    Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2  Canada

    PRODUCT OF CANADA

  • CARTON

    IMAGE OF CARTONIMAGE OF LABEL

  • INGREDIENTS AND APPEARANCE
    DIGESTION RELIEF 
    dolichos pruriens, lycopodium clavatum, leptandra virginica, carduus marianus, chelidonium majus, boldo pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C) MUCUNA PRURIENS FRUIT TRICHOME3 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE3 [hp_X]
    VERONICASTRUM VIRGINICUM ROOT (UNII: M2O62YTN42) (CULVER'S ROOT - UNII:M2O62YTN42) VERONICASTRUM VIRGINICUM ROOT3 [hp_X]
    MILK THISTLE (UNII: 822I9LEJ7S) (MILK THISTLE - UNII:822I9LEJ7S) MILK THISTLE3 [hp_X]
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS1 [hp_X]
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9057-180 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2013
    Labeler - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(60512-9057)
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