Label: CARDUUS PLEX- belladonna, carduus marianus, chelidonium majus, cholesterinum, cinchona succirubra, colocynthis, leptandra virginica, lycopodium clavatum, podophyllum peltatum, taraxacum officinale liquid

  • Category: HUMAN OTC DRUG LABEL

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 14, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients

    Each drop contains:

    Belladonna (Deadly nightshade) Whole Plant 4X (<1 x 10-6 % alkaloids, calculated)
    Carduus marianus (Milk thistle) Fruit 2X
    Chelidonium majus (Greater celandine) Rhizome and Root 2X
    Cholesterinum (Cholesterol) 4X
    Cinchona succirubra (Peruvian bark) Bark 3X
    Colocynthis (Bitter apple) Fruit 6X
    Leptandra virginica (Culver’s root) Underground Parts
    Lycopodium clavatum (Clubmoss) Spores 4X
    Podophyllum peltatum (Mayapple) Underground Parts 4X
    Taraxacum officinale (Common dandelion)Whole Plant 2X

  • PURPOSE

    Uses
    Helps promote and maintain overall digestive health.

    For the temporary relief of symptoms associated with poor digestion.

  • WARNINGS

    Warnings
    Stop use and ask a doctor if symptoms persist or worsen.
    If pregnant or breastfeeding, ask a health professional before use.
    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • OTHER SAFETY INFORMATION

    Other information

    • Do not use if seal is missing or broken.
    • Store in a cool, dry place.
    • Contents may not fill package in order to accommodate required labeling.Please rely on stated quantity.
  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), glycerin, purified water

  • DOSAGE & ADMINISTRATION

    Directions
    To be taken ten minutes away from food.
    Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
    Hold contents for about 20 seconds and swallow.
    To promote drop flow, invert bottle and shake before each use.

    Adults and adolescents (12 years and older)

    Take 10 drops three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses

    Helps promote and maintain overall digestive health.
    For the temporary relief of symptoms associated with poor digestion.

    Directions
    To be taken ten minutes away from food.
    Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.

    Hold contents for about 20 seconds and swallow.
    To promote drop flow, invert bottle and shake before each use.

    Adults and adolescents (12 years and older)

    Take 10 drops three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years)
    Take under the direction of your healthcare practitioner.

  • PRINCIPAL DISPLAY PANEL

    Box Image

    NDC 62106-1200-0

    UNDA

    plex

    CARDUUS PLEX

    Homeopathic Preparation

    For the temporary relief of symptoms associated with poor digestion.

    Contains 45% Alcohol
    1 fl oz (30 mL)

  • INGREDIENTS AND APPEARANCE
    CARDUUS PLEX 
    belladonna, carduus marianus, chelidonium majus, cholesterinum, cinchona succirubra, colocynthis, leptandra virginica, lycopodium clavatum, podophyllum peltatum, taraxacum officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE2 [hp_X]  in 30 mL
    CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL4 [hp_X]  in 30 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE4 [hp_X]  in 30 mL
    PODOPHYLLUM PELTATUM ROOT (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM PELTATUM ROOT4 [hp_X]  in 30 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE2 [hp_X]  in 30 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS2 [hp_X]  in 30 mL
    CULVER'S ROOT (UNII: M2O62YTN42) (CULVER'S ROOT - UNII:M2O62YTN42) CULVER'S ROOT1 [hp_X]  in 30 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]  in 30 mL
    CINCHONA PUBESCENS BARK (UNII: S96N10R972) (CINCHONA PUBESCENS BARK - UNII:S96N10R972) CINCHONA PUBESCENS BARK3 [hp_X]  in 30 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1200-01 in 1 CARTON05/18/2016
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/18/2016
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-1200)