Label: COMBINATION REMEDY 16 - MENOPAUSAL COMPLAINTS- cimicifuga racemosa, graphites, sanguinaria canadensis, sepia, sulphur solution/ drops

  • 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 25, 2017

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  • WARNINGS

    Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

    If pregnant or breast-feeding, ask health professional before use.

    Do not use if tamper evident seal is missing or broken.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • ACTIVE INGREDIENT

    Cimicifuga Racemosa 30X

    Graphites 30X

    Sanguinaria Canadensis 30X

    Sepia 30X

    Sulphur 30X

  • PURPOSE

    Temporary relief from menopausal complaints, periods that occur less often, headache, irritability, vaginal dryness, hot flashes, low libido.

  • INACTIVE INGREDIENT

    Purified Water

    Alcohol

  • DOSAGE & ADMINISTRATION

    Adults 18 years and older: Take 10-15 drops in half cup of water 3 times a day.

    Not inteded for use by persons under 18.

  • INDICATIONS & USAGE

    Temporary relief from menopausal complaints, periods that occur less often, headache, irritability, vaginal dryness, hot flashes, low libido.

  • PRINCIPAL DISPLAY PANEL

    menopausal complaints combo 16.jpg

  • INGREDIENTS AND APPEARANCE
    COMBINATION REMEDY 16 - MENOPAUSAL COMPLAINTS 
    cimicifuga racemosa, graphites, sanguinaria canadensis, sepia, sulphur solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69008-4016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 1 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE30 [hp_X]  in 1 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT30 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH30 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69008-4016-120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/15/2017
    Labeler - Warsan Homoeopathic Laboratories (645579772)
    Registrant - Warsan Homoeopathic Laboratories (645579772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Warsan Homoeopathic Laboratories645579772pack(69008-4016) , manufacture(69008-4016) , label(69008-4016)
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