Label: UNDA 1- achillea millefolium 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 7, 2022

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  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with
    indigestion
    fatigue following meals
    occasional headaches

  • 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.

  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:
    Angelica archangelica (European angelica) Root 4X
    Argentum metallicum (Silver) 12X
    Equisetum arvense (Common horsetail) Stem 4X
    Lycopodium clavatum (Clubmoss) Spore 4X
    Millefolium (Yarrow) Aerial Parts 4X
    Resina larcis (Larch turnpentine) Balsam 5X
    Uva-ursi (Bearberry) Leaf 4X
    Valeriana officinalis (Valerian) Root 4X

  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), purified water

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of symptoms associated with
    indigestion
    fatigue following meals
    occasional headaches

    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.

  • 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.

  • STOP USE

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

  • OTHER SAFETY INFORMATION

    Do not use if seal is missing or broken.

    Store in a cool dry place.

  • PRINCIPAL DISPLAY PANEL

    62106-1100-8

    NDC 62106-1100-8

    UNDA

    numbered compounds

    UNDA 1

    Homeopathic Preparation

    For the temporary
    relief of symptoms associated with
    indigestion, fatigue following meals

    and occasional headaches.

    Contains 31% Alcohol

    0.7 fl oz (20 ml)

  • INGREDIENTS AND APPEARANCE
    UNDA 1 
    achillea millefolium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM4 [hp_X]  in 20 mL
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF4 [hp_X]  in 20 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN4 [hp_X]  in 20 mL
    ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN) (ANGELICA ARCHANGELICA ROOT - UNII:DTN01M69SN) ANGELICA ARCHANGELICA ROOT4 [hp_X]  in 20 mL
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z) EQUISETUM ARVENSE TOP4 [hp_X]  in 20 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE4 [hp_X]  in 20 mL
    LARIX DECIDUA RESIN (UNII: AD8LJ73GQF) (LARIX DECIDUA RESIN - UNII:AD8LJ73GQF) LARIX DECIDUA RESIN5 [hp_X]  in 20 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER12 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1100-81 in 1 CARTON07/01/2014
    120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2014
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1100)
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