Label: UNDA 243- boldo, cholesterinum, taraxacum officinale, lycopodium clavatum, podophyllum peltatum 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 November 9, 2022

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  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:
    Boldo Leaf 4X
    Cholesterinum (Cholesterol) 12X
    Taraxacum officinale (Common dandelion) Whole Plant 4X
    Lycopodium clavatum (Clubmoss) Spore 4X
    Podophyllum peltatum (Mayapple) Underground Parts 4X

  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with overindulgence in 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and adolescents (12 years and older)
    Take 5 drops three times daily or as recommended by your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of symptoms associated with overindulgence in food and alcohol.

    Directions
    Adults and adolescents (12 years and older)
    Take 5 drops three times daily or as recommended by your healthcare practitioner.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), purified water

  • 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

    62106-1196

    NDC 62106-1196-8

    UNDA

    numbered compounds

    UNDA 243

    Homeopathic Preparation

    For the temporary relief of symptoms

    associated with overindulgence in
    food and alcohol.

    Contains 31% Alcohol

    0.7 fl oz (20 mL)

  • INGREDIENTS AND APPEARANCE
    UNDA 243 
    boldo, cholesterinum, taraxacum officinale, lycopodium clavatum, podophyllum peltatum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1196
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE4 [hp_X]  in 20 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE4 [hp_X]  in 20 mL
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM4 [hp_X]  in 20 mL
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF4 [hp_X]  in 20 mL
    CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL12 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1196-81 in 1 CARTON04/01/2020
    120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2020
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1196)
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