Label: MENOPAUSE HF- cimicifuga racemosa, trifolium pratense, magnesia carbonica, agnus castus tablet

  • 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 31, 2012

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  • ACTIVE INGREDIENT

    Cimicifuga racemosa 1X HPUS       
    Trifolium pratense 1X HPUS             
    Magnesia carbonica 1X HPUS           
    Agnus castus 1X HPUS
  • PURPOSE

    Relieves hot flashes and
    mood changes

    Supportive phytoestrogens,
    isoflavones for other ingredients

    Relieves cramps, nervousness,
    and muscle spasms

    Improves melancholy and
    perimenopausal hormone imbalance
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Uses:Relieves hot flashes, mood changes associated with perimenopausal hormone changes.
  • WARNINGS

    Warnings

    Allergy Alert: Rare allergic reaction to Red clover (Trifolium pratense): includes skin reactions; to Black Cohosh (Cimicfuga racemosa): includes stomach discomfort.
  • DOSAGE & ADMINISTRATION

    Directions:
    Adults take 1 or 2 tablets 3 times daily with meals.  An extra
    dose may be taken at bedtime if needed.  Do not exceed 10
    tablets in a 24 hour period.  The smallest effective dose should
    be used.  Do not give to children under 12.  Do not exceed
    recommended dose.

    Other Information:
    B-complex vitamins are complementary when used within
    the same day as this drug.  1X indicates a 1:9 homeopathic
    diluted ingredient.  The letters HPUS indicate that these ingre-
    dients are officially included in the Homeopathic
    Pharmacopeia of the United States.  Store at controlled room
    temperature 59-86F (15-30 C)  Do not use if imprinted
    safety seal under cap is broken or missing.
  • INACTIVE INGREDIENT

    Inactive ingredients: Lactose, vegetable stearic acid, vegetable
    cellulose, vegetable magnesium stearate.
  • PRINCIPAL DISPLAY PANEL

    Product Label Image

  • INGREDIENTS AND APPEARANCE
    MENOPAUSE  HF
    cimicifuga racemosa, trifolium pratense, magnesia carbonica, agnus castus tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64175-525
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh1 [hp_X]
    Red Clover (UNII: L9153EKV2Y) (Red Clover - UNII:L9153EKV2Y) Red Clover1 [hp_X]
    Magnesium Carbonate (UNII: 0E53J927NA) (Magnesium - UNII:I38ZP9992A) Magnesium Carbonate1 [hp_X]
    Chaste Tree (UNII: 433OSF3U8A) (Chaste Tree - UNII:433OSF3U8A) Chaste Tree1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Lactose (UNII: J2B2A4N98G)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorbrown (Light brown with dark brown speckels) Scoreno score
    ShapeROUND (Tablet) Size11mm
    FlavorImprint Code M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64175-525-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2010
    Labeler - Foster Regal Laboratories (807396481)
    Registrant - Dee Cee Laboratories (034731893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dee Cee Laboratories034731893manufacture
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