Label: MENOPAUSE- amyl nitrosum, calcarea carbonica, caulophyllum thalictroides, cimicifuga racemosa, ferrum metallicum, gelsemium sempervirens, lachesis mutus, pulsatilla, sanguinaria canadensis, sepia, sulphur, sulphuricum acidum 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 October 24, 2014

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  • DOSAGE & ADMINISTRATION

    Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

    Adult Dose: 3 Pump Sprays

    Child's Dose (2-12): 2 Pump Sprays

    Infants - 2 yrs. 1 Pump Spray

  • WARNINGS

    Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Other information: Tamper resistant for your protection. Use only if safety seal is intact.

  • PURPOSE

    Indications: For temporary relief of discomforts associated with menopause: •hot flashes •sweats •chills/clammy skin •heat in the head •headaches •hot feet •mood swings •anxiety/sensitivity •wanting to be alone

  • ACTIVE INGREDIENT

    Active Ingredients: ​Amyl nitrosum, Calcarea carbonica, Caulophyllum thalictroides, Cimicifuga racemosa, Ferrum metallicum, Gelsemium sempervirens, Lachesis mutus, pulsatilla, Sanguinaria canadensis, Sepia, Sulphur, Sulphuricum acidum. ​Equal volumes of each ingredient in 10X, 30X, and 100X potencies.

  • INACTIVE INGREDIENT

    Inactive Ingredient: Citric acid, potassium sorbate, purified water.

  • INDICATIONS & USAGE

    Indications: For temporary relief of discomforts associated with menopause:

    • hot flashes
    • sweats
    • chills/clammy skin
    • heat in the head
    • headaches
    • hot feet
    • mood swings
    • anxiety/sensitivity
    • wanting to be alone
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MENOPAUSE 
    amyl nitrosum, calcarea carbonica, caulophyllum thalictroides, cimicifuga racemosa, ferrum metallicum, gelsemium sempervirens, lachesis mutus, pulsatilla, sanguinaria canadensis, sepia, sulphur, sulphuricum acidum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66579-0080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMYL NITRITE (UNII: 22T8Z09XAK) (AMYL NITRITE - UNII:22T8Z09XAK) AMYL NITRITE10 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 59 mL
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT10 [hp_X]  in 59 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 59 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON10 [hp_X]  in 59 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 59 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT10 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66579-0080-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/22/2012
    Labeler - New Sun Inc. (957251176)
    Registrant - New Sun Inc. (957251176)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(66579-0080)
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