Label: UNDA 228- valeriana officinalis root, melissa officinalis whole plant, verbena officinalis whole plant, millefolium whole plant, thymus vulgaris aerial parts, passiflora incarnata aerial parts, lactuca virosa whole plant 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 October 4, 2017

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

  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:
    Lactuca virosa (Poisonous lettuce) Whole Plant 4X
    Melissa officinalis (Lemon balm) Leaf/Young Shoot 4X
    Millefolium (Yarrow) Aerial Parts 4X
    Passiflora incarnata (Passion flower) Aerial Parts 4X
    Thymus vulgaris Aerial Parts 4X
    Valeriana officinalis (Valerian) Root 4X
    Verbena officinalis (Common vervain) Aerial Parts 4X.

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  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with occasional stress.

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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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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • OVERDOSAGE

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

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  • ASK DOCTOR

    Stop use and ask a doctor if symptoms persist or worsen.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Ethanol (beet),
    purified water

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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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  • 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
    For the temporary relief of symptoms associated with occasional stress.

    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

    62106-1159

    NDC 62106-1159-8

    UNDA

    numbered compounds

    UNDA 228

    Homeopathic Preparation

    For the temporary relief
    of symptomsassociated with
    occasional stress.

    Contains 31% Alcohol

    0.7 fl oz (20 ml)

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  • INGREDIENTS AND APPEARANCE
    UNDA 228 
    valeriana officinalis root, melissa officinalis whole plant, verbena officinalis whole plant, millefolium whole plant, thymus vulgaris aerial parts, passiflora incarnata aerial parts, lactuca virosa whole plant liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1159
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS 4 [hp_X]  in 20 mL
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 4 [hp_X]  in 20 mL
    LACTUCA VIROSA (UNII: 6D74QW4H67) (LACTUCA VIROSA - UNII:6D74QW4H67) LACTUCA VIROSA 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
    VERBENA OFFICINALIS (UNII: QT8A71T9BM) (VERBENA OFFICINALIS - UNII:QT8A71T9BM) VERBENA OFFICINALIS 4 [hp_X]  in 20 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 4 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62106-1159-8 1 in 1 BOX 12/17/2014
    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 12/17/2014
    Labeler - Seroyal USA (018361118)
    Establishment
    Name Address ID/FEI Business Operations
    Unda SA 400346069 manufacture(62106-1159)
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