Label: CALM REMEDY WATER- aconitum nap., arg. nit., aut. met., baptisia, bryonia, chelidonium majus, cimicifuga, conium, gelsemium, ignatia, kali carb., lachesis, lilum, lycopodium, nat. carb., nat. mur., phosphoricum ac., phosphorus, picricum ac., plumb. met., sepia, staphysag., stramonium, thuja occ., zinc. met., chomomilla, hypericum, valeriana 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 June 10, 2012

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Aconitum napellus15x
    Argentum nitricum15x
    Aurum metallicum15x
    Baptisia15x
    Bryonia 15x
    Chelidonium majus15x
    Cimicifuga racemosa15x
    Conium maculatum15x
    Gelsemium sempervirens15x
    Ignatia amara15x
    Kali carbonicum15x
    Lachesis mutus15x
    Lilum tigrinum15x
    Lycopodium clavatum15x
    Natrum carbonicum15x
    Natrum muriaticum15x
    Phosphoricum acidum15x
    Phosphorus15x
    Picricum acidum15x
    Plumbum metallicum15x
    Sepia15x
    Staphysagria15x
    Stramonium15x
    Thuja occidentalis15x
    Zincum metallicum15x
    Chamomilla  3x
    Hypericum perforatum  3x
    Valeriana officinalis  3x
  • Purpose

    Formulated for symptoms associated with stress and tension such as worry, frustration, emotional sensitivity and feeling mentally and physically drained.

  • Uses

    Formulated for symptoms associated with stress and tension such as worry, frustration, emotional sensitivity and feeling mentally and physically drained.

  • Warnings

    Do not use if tamper-evident package seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

  • Directions

    Ages 12 and up. Remedy Water® homepathic pellets are dispersed via the PowerCap® apparatus. Firmly press PowerCap® dome to release pellets into the bottle of water and shake well. Remedy Water® pellets may not dissolve completely. Drink within four hours. Avoid storing or washing where temperatures may exceed 140 degrees.

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive Ingredients

    USP/NF neutral pellets (.07% gluten-free, non-GMO, beet-derived sucrose, .03% gluten-free, non-GMO maize starch in 500 ml water)

  • Other Information

     Avoid storing in areas where temperatures may exceed 140 degrees.

  • Questions?

    1.866.777.1277
    www.RemedyWater.com

  • PRINCIPAL DISPLAY PANEL

    NDC# 35378-0004-2

    EssentiaLIFE Homeopathics™

    CALM Remedy Water®

    Formulated for symptoms associated with stress and tension such as frustration, worry, emotional sensitivity and feeling mentally and physically drained.

    Seven PowerCaps® - 1 gram each

    Directions: Ages 12 and up. Remedy Water® homepathic pellets are dispersed via the PowerCap® apparatus. Firmly press PowerCap® dome to release pellets into the bottle of water and shake well. Remedy Water® pellets may not dissolve completely. Drink within four hours. Avoid storing or washing where temperatures may exceed 140 degrees.

    IT'S ALL IN THE CAP
    NEVER A PRESERVATIVE
    1. PUSH
    2. SHAKE

    Please Recyle

    Patent Pending

    Boosted by PowerCap®

    FDA Registered and Regulated

    NO PRESERVATIVES

    ZERO CALORIES

    BPA-FREE BOTTLE

    Active Ingredients: Aconitum napellus 15x, Argentum nitricum 15x, Aurum  metallicum 15x, Baptisia 15x, Bryonia 15x, Chelidonium majus 15x, Cimicifuga racemosa 15x, Conium maculatum 15x, Gelsemium sempervirens 15x, Ignatia amara 15x, Kali carbonicum 15x, Lachesis mutus 15x, Lilium tigrinum 15x, Lycopodium clavatum 15x, Natrum carbonicum 15x, Natrum muriaticum 15x, Phosphoricum acidum 15x, Phosphorus 15x, Picricum acidum 15x, Plumbum metallicum 15x, Sepia 15x, Staphysagria 15x, Stramonium 15x, Thuja occidentalis 15x, Zincum metallicum 15x, Chamomilla 3x, Hypericum perforatum 3x, Valeriana officinalis 3x.

    Inactive ingredients: USP/NF neutral pellets (.07% gluten-free, non-GMO, beet-derived sucrose, .03% gluten-free, non-GMO maize starch in 500 ml water)

    Stock# EW02

    Lot# 01GEW02

    www.RemedyWater.com

    Distributed by EssentiaLIFE

    FDA Est.# 3006407415 Atlanta, GA 30328

    Questions?

    1.866.777.1277

    Warning: Do not use if tamper-evident package seal is broken or missing.  Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.  Keep out of reach of children.

    Calm Water Label
  • INGREDIENTS AND APPEARANCE
    CALM REMEDY WATER  
    aconitum nap., arg. nit., aut. met., baptisia, bryonia, chelidonium majus, cimicifuga, conium, gelsemium, ignatia, kali carb., lachesis, lilum, lycopodium, nat. carb., nat. mur., phosphoricum ac., phosphorus, picricum ac., plumb. met., sepia, staphysag., stramonium, thuja occ., zinc. met., chomomilla, hypericum, valeriana pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35378-0004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus15 [hp_X]  in 1 mg
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 mg
    Gold (UNII: 79Y1949PYO) (Gold - UNII:79Y1949PYO) Gold15 [hp_X]  in 1 mg
    Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root15 [hp_X]  in 1 mg
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mg
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mg
    Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh15 [hp_X]  in 1 mg
    Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top15 [hp_X]  in 1 mg
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root15 [hp_X]  in 1 mg
    Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed15 [hp_X]  in 1 mg
    Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate15 [hp_X]  in 1 mg
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 mg
    Lilium Lancifolium Bulb (UNII: 47Z05W73EZ) (Lilium Lancifolium Bulb - UNII:47Z05W73EZ) Lilium Lancifolium Bulb15 [hp_X]  in 1 mg
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mg
    Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D) Sodium Carbonate15 [hp_X]  in 1 mg
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride15 [hp_X]  in 1 mg
    Phosphoric Acid (UNII: E4GA8884NN) (Phosphoric Acid - UNII:E4GA8884NN) Phosphoric Acid15 [hp_X]  in 1 mg
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mg
    Trinitrophenol (UNII: A49OS0F91S) (Trinitrophenol - UNII:A49OS0F91S) Trinitrophenol15 [hp_X]  in 1 mg
    Lead (UNII: 2P299V784P) (Lead - UNII:2P299V784P) Lead15 [hp_X]  in 1 mg
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 mg
    Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed15 [hp_X]  in 1 mg
    Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium15 [hp_X]  in 1 mg
    Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig15 [hp_X]  in 1 mg
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 [hp_X]  in 1 mg
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita3 [hp_X]  in 1 mg
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum3 [hp_X]  in 1 mg
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize1mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35378-0004-27 in 1 CONTAINER
    11000 mg in 1 CYLINDER
    2NDC:35378-0004-31 in 1 CONTAINER
    21000 mg in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2012
    Labeler - Georgetown Health, LLC DBA EssentiaLife (111513086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(35378-0004)