Label: UNDA 219- crataegus, lactuca virosa, passiflora incarnata, thymus vulgaris, valeriana officinalis 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 March 27, 2016

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

  • ACTIVE INGREDIENT

    Active ingredients

    Each drop contains:
    Crataegus (Hawthorn) Fruit 4X
    Lactuca virosa (Poisonous lettuce) Whole Plant 4X
    Passiflora incarnata (Passion flower) Aerial Parts 4X
    Thymus vulgaris Aerial Parts 4X
    Valeriana officinalis (Valerian) Root 4X

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  • PURPOSE

    Uses
    Helps to promote relaxation and temporarily relieve mild nervousness

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • PREGNANCY OR BREAST FEEDING

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

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  • OTHER SAFETY INFORMATION

    Other information
    Do not use if seal is missing or broken.
    Store in a cool, dry place.

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  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), purified water

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  • DOSAGE & ADMINISTRATION

    Directions
    Adults and adolescents (12 years and older)

    Take 5 drops three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner

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  • INDICATIONS & USAGE

    Uses
    Helps to promote relaxation and temporarily relieve mild nervousness

    Directions
    Adults and adolescents (12 years and older): Take 5 drops three times daily or as
    recommended by your healthcare practitioner.
    Children (under 12 years): Take under the direction of your
    healthcare practitioner.

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  • PRINCIPAL DISPLAY PANEL

    62106-1156

    NDC 62106-1156-8

    UNDA

    numbered compounds

    UNDA 219

    Homeopathic Preparation

    Helps to promote relaxation and temporarily relieve mild nervousness.

    Contains 31% Alcohol
    0.7 fl oz (20 ml)

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  • INGREDIENTS AND APPEARANCE
    UNDA 219 
    crataegus, lactuca virosa, passiflora incarnata, thymus vulgaris, valeriana officinalis liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1156
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CRATAEGUS FRUIT (UNII: Q21UUL2105) (CRATAEGUS FRUIT - UNII:Q21UUL2105) CRATAEGUS FRUIT 4 [hp_X]  in 20 mL
    THYME (UNII: CW657OBU4N) (THYME - UNII:CW657OBU4N) THYME 4 [hp_X]  in 20 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 4 [hp_X]  in 20 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 4 [hp_X]  in 20 mL
    LACTUCA VIROSA (UNII: 6D74QW4H67) (LACTUCA VIROSA - UNII:6D74QW4H67) LACTUCA VIROSA 4 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62106-1156-8 1 in 1 CARTON 03/27/2016
    1 20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/27/2016
    Labeler - Seroyal USA (018361118)
    Establishment
    Name Address ID/FEI Business Operations
    Unda SA 400346069 manufacture(62106-1156)
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