Label: FEM REMEDY- amyl nitrosum, calcarea carbonica, cimicifuga racemosa, ferrum metallicum, sanguinaria canadensis, sepia 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 April 16, 2014

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  • DOSAGE & ADMINISTRATION

    Directions: Spray 3 times directly into mouth under your tongue. Take 3 times daily. Take additional doses as needed during hot flashes and night sweats. Continue until symptoms are relieved.

  • WARNINGS

    Warnings: Stop use and ask a doctor, if symptoms persist or worsen. If pregnant or breast-feeding, consult a healthcare professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Other: Do not use if safety seal is broken or missing.

  • PURPOSE

    Uses: May help to relieve premenopause and menopause symptoms: hot flashes, night sweats, mood swings, low energy, irritability, difficulty sleeping, fatigue, sadness, hair loss, difficulty concentrating.

  • ACTIVE INGREDIENT

    Ingredients: Official HPUS:Amyl nitrosum, Calcarea carbonica, Cimicifuga racemosa, Ferrum metallicum, Sanguinaria canadensis, Sepia. Equal volumes of each ingredient in 10C, 30C, LM1 potencies.

  • INACTIVE INGREDIENT

    Inactive ingredients: Bio-Energetically enhanced pure water, citric acid, potassium sorbate.

  • INDICATIONS & USAGE

    Uses: May help to relieve premenopause and menopause symptoms:

    • hot flashes
    • night sweats
    • mood swings
    • low energy
    • irritability
    • difficulty sleeping
    • fatigue
    • sadness
    • hair loss
    • difficulty concentrating
  • PRINCIPAL DISPLAY PANEL

    image description

    Distributed by

    Living Well Remedies LLC

    P.O. Box 704,

    Franklin Lakes, NJ 07417

    For more information visit:

    www.livingWellRenedies.com

  • INGREDIENTS AND APPEARANCE
    FEM REMEDY 
    amyl nitrosum, calcarea carbonica, cimicifuga racemosa, ferrum metallicum, sanguinaria canadensis, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53852-0008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMYL NITRITE (UNII: 22T8Z09XAK) (AMYL NITRITE - UNII:22T8Z09XAK) AMYL NITRITE10 [hp_C]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_C]  in 59 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_C]  in 59 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON10 [hp_C]  in 59 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT10 [hp_C]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53852-0008-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/16/2014
    Labeler - Living Well Remedies, LLC (022609201)
    Registrant - Living Well Remedies, LLC (022609201)
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