Label: CHELIDONIUM PLEX- chelidonium majus, carduus marianus, solidago virgaurea, berberis vulgaris, dolichos pruriens, iris versicolor, ptelea trifoliata, taraxacum officinale 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 July 14, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients

    Each drop contains:

    Berberis vulgaris (Barberry) Bark 10X
    Carduus marianus (Milk thistle) Fruit 3X
    Chelidonium majus (Greater celandine) Rhizome and Root 10X
    Dolichos pruriens (Cowhage) Dried Fruit Hairs 10X
    Iris versicolor (Blue flag) Underground Parts 10X
    Ptelea trifoliata (Hop tree) Leaf and Twig Bark 10X
    Solidago virgaurea (Goldenrod) Inflorescences 3X
    Taraxacum officinale (Common dandelion) Whole Plant 10X

  • PURPOSE

    Uses
    Helps promote and maintain healthy liver and kidney function.
    Temporarily alleviates symptoms associated with overindulgence of food and alcohol.

  • 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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), purified water

  • DOSAGE & ADMINISTRATION

    Directions:

    To be taken ten minutes away from food.

    Children: Divided dosage by half and follow adult directions.

    Invert bottle and shake lightly allowing for drops to fall directly under the tongue or into 1/4 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 healthy liver and kidney function.
    Temporarily alleviates symptoms associated with overindulgence of food and alcohol.

    Directions

    To be taken ten minutes away from food.

    Invert bottle and shake lightly allowing for drops to fall directly under the tongue or into 1/4 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.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    62106-1201-0

    NDC 62106-1201-0

    UNDA

    plex

    CHELIDONIUM PLEX

    Homeopathic Preparation

    Temporarily alleviates symptoms
    associated with overindulgence
    of food and alcohol.

    Contains 25% Alcohol
    1 fl oz (30 mL)

  • INGREDIENTS AND APPEARANCE
    CHELIDONIUM PLEX 
    chelidonium majus, carduus marianus, solidago virgaurea, berberis vulgaris, dolichos pruriens, iris versicolor, ptelea trifoliata, taraxacum officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PTELEA TRIFOLIATA BARK (UNII: 5KQR6FTT0D) (PTELEA TRIFOLIATA BARK - UNII:5KQR6FTT0D) PTELEA TRIFOLIATA BARK10 [hp_X]  in 30 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE10 [hp_X]  in 30 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK10 [hp_X]  in 30 mL
    MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C) MUCUNA PRURIENS FRUIT TRICHOME10 [hp_X]  in 30 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT10 [hp_X]  in 30 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS10 [hp_X]  in 30 mL
    MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE3 [hp_X]  in 30 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1201-01 in 1 BOX12/17/2014
    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 homeopathic12/17/2014
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-1201)