UNDA 219 (CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, THYMUS VULGARIS, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]

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  • UNDA 219 (CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, THYMUS VULGARIS, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]

UNDA 219 (CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, THYMUS VULGARIS, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]
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NDC 62106-1156-8
Set ID 2f0cd4d0-55ab-64b4-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Seroyal USA
Generic Name
Product Class
Product Number
Application Number
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  • 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

  • PURPOSE

    Uses
    Helps to promote relaxation and temporarily relieve mild nervousness

  • 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.

  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), purified water

  • 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

  • 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.

  • 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)

  • INGREDIENTS AND APPEARANCE
    UNDA 219 
    crataegus, lactuca virosa, passiflora incarnata, thymus vulgaris, valeriana officinalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1156
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CRATAEGUS FRUIT (UNII: Q21UUL2105) (CRATAEGUS FRUIT - UNII:Q21UUL2105) CRATAEGUS FRUIT4 [hp_X]  in 20 mL
    THYME (UNII: CW657OBU4N) (THYME - UNII:CW657OBU4N) THYME4 [hp_X]  in 20 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP4 [hp_X]  in 20 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN4 [hp_X]  in 20 mL
    LACTUCA VIROSA (UNII: 6D74QW4H67) (LACTUCA VIROSA - UNII:6D74QW4H67) LACTUCA VIROSA4 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1156-81 in 1 CARTON03/27/2016
    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 homeopathic03/27/2016
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1156)
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