Label: ESTROGEN AND PROGESTERONE (agnus castus, angelica sinensis, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, glycyrrhiza glabra, korean ginseng, oophorinum- suis, progesterone, sepia, thuja occidentalis, viscum album spray

  • 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 January 12, 2017

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

View All Sections
  • ACTIVE INGREDIENTS:

    Agnus Castus 3X, Angelica Sinensis 3X, Apis Mellifica 6X, Arnica Montana 6X, Cimicifuga Racemosa 3X, Estradiol 9C, Estriol 9C, Folliculinum 9C, Galium Aparine 3X, Glycyrrhiza Glabra 3X, Korean Ginseng 3X, Oophorinum (Suis) 30C, Progesterone 6X, Sepia 30C, Thuja Occidentalis 6X, Viscum Album 3X

  • INDICATIONS:

    Temporarily supports the body to rebalance estrogen output.  Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

  • WARNINGS:

    Not for use on children.

    If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness.

    As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Tamper Evident. There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.

  • INDICATIONS:

    Temporarily supports the body to rebalance estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

  • INACTIVE INGREDIENTS:

    Organic Alcohol 30% v/v, Purified Water

  • QUESTIONS:

    Distributed By ProBLEN
    2850 Shoreline Trail,
    Rockwall, TX 75032
    www.problen.com

  • PACKAGE LABEL DISPLAY:

    HOMEOPATHIC

    ORGANOTHERAPY

    Estro

    gen

    &

    Progesterone

    1.0 FL. OZ. (30ML)

    proBLEN

    Estrogen & Progesterone lbl

    Estrogen & Progesterone ctn

  • INGREDIENTS AND APPEARANCE
    ESTROGEN AND PROGESTERONE 
    agnus castus, angelica sinensis, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, glycyrrhiza glabra, korean ginseng, oophorinum (suis), progesterone, sepia, thuja occidentalis, viscum album spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43853-0017
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE3 [hp_X]  in 1 mL
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT3 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]  in 1 mL
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL9 [hp_C]  in 1 mL
    ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E) ESTRIOL9 [hp_C]  in 1 mL
    ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE9 [hp_C]  in 1 mL
    GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE3 [hp_X]  in 1 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA3 [hp_X]  in 1 mL
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG3 [hp_X]  in 1 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY30 [hp_C]  in 1 mL
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE6 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_C]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]  in 1 mL
    VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43853-0017-21 in 1 CARTON01/12/2017
    1NDC:43853-0017-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/12/2017
    Labeler - ProBLEN (838787161)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43853-0017) , api manufacture(43853-0017) , label(43853-0017) , pack(43853-0017)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!