Label: PMS RELIEF- cimicifuga racemosa, mercurius corrosivus, sabina, hydrastis canadensis, secale cornutum, aurum metallicum, hyoscyamus niger, lycopodium clavatum, nitricum acidum pellet

  • 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 October 18, 2013

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  • ACTIVE INGREDIENTS HPUS

    Cimicifuga racemosa 4X

    Mercurius corrosivus 9X

    Sabina 8X

    Hydrastis canadensis 4X

    Secale cornutum 3X

    Aurum metallicum 9X

    Hyoscyamus niger 3C

    Lycopodium clavatum 4X

    Nitricum acidum 9X

  • REFERENCES

    Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

  • PURPOSE

    Relief of Menstrual Cramping, Irritability, Anxiety and Fatigue

  • USES

    This is a natural Homeopathic remedy that relieves menstrual cramping, irritability, anxiety and fatigue.

  • WARNINGS

  • ASK DOCTOR

    If symptoms persist or worsen, discontinue use and contact a health professional.

  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications out of reach of children.

  • DIRECTIONS

    Adults: Allow 3 to 4 pellets to dissolve in mouth three times a day.

    Not for use by children.

  • OTHER INFORMATION

    Do not use if cap seal is broken.

    Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2  Canada

    PRODUCT OF CANADA

  • CARTON

    IMAGE OF CARTONIMAGE OF LABEL

  • INGREDIENTS AND APPEARANCE
    PMS RELIEF 
    cimicifuga racemosa, mercurius corrosivus, sabina, hydrastis canadensis, secale cornutum, aurum metallicum, hyoscyamus niger, lycopodium clavatum, nitricum acidum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT) (ACTAEA CIMICIFUGA ROOT - UNII:65J267BAZT) ACTAEA CIMICIFUGA ROOT4 [hp_X]
    MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE9 [hp_X]
    JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1) JUNIPERUS SABINA LEAFY TWIG8 [hp_X]
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T) HYDRASTIS CANADENSIS WHOLE4 [hp_X]
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM3 [hp_X]
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD9 [hp_X]
    HYOSCYAMUS NIGER WHOLE (UNII: 34412PDT5E) (HYOSCYAMUS NIGER WHOLE - UNII:34412PDT5E) HYOSCYAMUS NIGER WHOLE3 [hp_C]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE4 [hp_X]
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID9 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-0001-180 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2013
    Labeler - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(60512-0001)
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