Label: HFE (apis mellifica, belladonna, caulophyllum thalictroides, cimicifuga racemosa, dioscorea villosa, gelsemium sempervirens, helonias dioica, magnesia phosphorica, oryctolagus cuniculus (rabbit) adrenal gland, oryctolagus cuniculus (rabbit) ovary, oryctolagus cuniculus- rabbit uterus, viburnum opulus 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 July 22, 2021

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  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:
    Apis mellifica 5X
    Belladonna Whole Plant 4X
    (< 10-6 % alkaloids, calculated)
    Caulophyllum thalictroides Underground Parts 4X
    Cimicifuga racemosa Root/Rhizome 6X
    Dioscorea villosa Underground Parts 4X
    Gelsemium sempervirens Root 8X
    Helonias dioica Root/Rhizome 4X
    Magnesia phosphorica 10X

    Oryctolagus cuniculus (Rabbit) Adrenal Gland 10X
    Oryctolagus cuniculus (Rabbit) Ovary 10X

    Oryctolagus cuniculus (Rabbit) Uterus 10X
    Viburnum opulus Bark 2X

  • PURPOSE

    Uses

    Helps promote and maintain general female reproductive health.
    Product 'Uses' are based on Homeopathic Materia Medica and have not been clinically tested. These 'Uses' have not been evaluated by the Food and Drug Administration.

  • 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.

  • OVERDOSAGE

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

  • STOP USE

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

  • OTHER SAFETY INFORMATION

    Other information

    Store in a cool, dry place.

    Use only if safety seal is intact

    Contents may not fill package in order to accomodate required labelling. Please rely on stated quantity.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Ethanol (beet), purified water

  • DOSAGE & ADMINISTRATION

    Directions

    To be taken 20 minutes away from food. Place drops directly under the tongue or into ¼ oz of water.

    Adults and adolescents (12 years and older): Take 10 drops two to 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 promote and maintain general female reproductive health.
    Product 'Uses' are based on Homeopathic Materia Medica and have not been clinically tested. These 'Uses' have not been evaluated by the Food and Drug Administration.

    Directions

    To be taken 20 minutes away from food. Place drops directly under the tongue or into ¼ oz of water.

    Adults and adolescents (12 years and older): Take 10 drops two to 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

    62106-0623-0

    NDC 62106-0623-0

    HFE

    HOMEOPATHIC PREPARATION

    To help promote and maintain
    female reproductive health.

    Contains 31% Alcohol

    1 fl oz (30 mL)

  • INGREDIENTS AND APPEARANCE
    HFE 
    apis mellifica, belladonna, caulophyllum thalictroides, cimicifuga racemosa, dioscorea villosa, gelsemium sempervirens, helonias dioica, magnesia phosphorica, oryctolagus cuniculus (rabbit) adrenal gland, oryctolagus cuniculus (rabbit) ovary, oryctolagus cuniculus (rabbit) uterus, viburnum opulus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-0623
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA ROOT4 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS OVARY (UNII: XA09528U2R) (ORYCTOLAGUS CUNICULUS OVARY - UNII:XA09528U2R) ORYCTOLAGUS CUNICULUS OVARY10 [hp_X]  in 30 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA5 [hp_X]  in 30 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]  in 30 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH6 [hp_X]  in 30 mL
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT4 [hp_X]  in 30 mL
    CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT4 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS ADRENAL GLAND (UNII: QGY289M89Q) (ORYCTOLAGUS CUNICULUS ADRENAL GLAND - UNII:QGY289M89Q) ORYCTOLAGUS CUNICULUS ADRENAL GLAND10 [hp_X]  in 30 mL
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK2 [hp_X]  in 30 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT8 [hp_X]  in 30 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS UTERUS (UNII: NQX84Z32G6) (ORYCTOLAGUS CUNICULUS UTERUS - UNII:NQX84Z32G6) ORYCTOLAGUS CUNICULUS UTERUS10 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-0623-030 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/18/2018
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-0623)
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