Label: UNDA 245- rheum, viburnum prunifolium, thuja occidentalis, pulsatilla, fagopyrum esculentum 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 December 18, 2019

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

  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:
    Fagopyrum esculentum (Buckwheat) Aerial Parts 4X
    Pulsatilla (Wind flower) Whole Plant 4X
    Rheum (Chinese rhubarb) Underground Parts 4X
    Thuja occidentalis (White cedar) Twig 4X
    Viburnum prunifolium (Blackhaw) Bark 4X

  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with minor menstrual pains.

  • 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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • 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.

  • 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
    For the temporary relief of symptoms associated with minor menstrual pains.

    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

    62106-1163

    NDC 62106-1163-8

    UNDA

    numbered compounds

    UNDA 245

    Homeopathic Preparation

    For the temporary relief of symptoms
    associated with minor menstrual pains.

    Contains 32% Alcohol
    0.7 fl oz (20 mL)

  • INGREDIENTS AND APPEARANCE
    UNDA 245 
    rheum, viburnum prunifolium, thuja occidentalis, pulsatilla, fagopyrum esculentum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1163
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RHEUM TANGUTICUM WHOLE (UNII: QH89N6B02U) (RHEUM TANGUTICUM WHOLE - UNII:QH89N6B02U) RHEUM TANGUTICUM WHOLE4 [hp_X]  in 20 mL
    VIBURNUM PRUNIFOLIUM BARK (UNII: J411UTU0HN) (VIBURNUM PRUNIFOLIUM BARK - UNII:J411UTU0HN) VIBURNUM PRUNIFOLIUM BARK4 [hp_X]  in 20 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG4 [hp_X]  in 20 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS4 [hp_X]  in 20 mL
    FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM4 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1163-81 in 1 CARTON01/19/2015
    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 homeopathic01/19/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1163)