Label: MUSCLE EASE- aconitum nap., antimon. tart.,arg. nit., arnica, bryonia, chamomilla,chelidonium majus, cimicifuga, eupatorium perf.,hypericum, nux vom., rhus toxicodendron, ruta,sarcolacticum ac., stramonium, strychninum,chamomilla, phytolacca, ruta, symphytum. 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 March 1, 2011

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  • INDICATIONS & USAGE SECTION

    Muscle Ease  Formulated for symptoms associated with muscle discomfort such as bruising, pain, soreness, stiffness, spasms and weakness.

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Aconitum nap. 15x, Antimon. tart. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Chamomilla 15x, Chelidonium majus 15x, Cimicifuga 15x, Eupatorium perf. 15x, Hypericum 15x, Nux vom. 15x, Rhus toxicodendron 15x, Ruta 15x,Sarcolacticum ac. 15x, Stramonium 15x, Strychninum 15x, Chamomilla 3x, Phytolacca 3x, Ruta 3x, Symphytum 3x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with muscle discomfort such as bruising, pain, soreness, stiffness, spasms and weakness.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

  • QUESTIONS SECTION

    www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions?  1.800.448.7256

  • WARNINGS SECTION

    Warning: Do not use if tamper - evident 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

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    MUSCLE EASE  
    aconitum nap., antimon. tart.,arg. nit., arnica, bryonia, chamomilla,chelidonium majus, cimicifuga, eupatorium perf.,hypericum, nux vom., rhus toxicodendron, ruta,sarcolacticum ac., stramonium, strychninum,chamomilla, phytolacca, ruta, symphytum. pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2273
    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 g
    Antimony Potassium Tartrate (UNII: DL6OZ476V3) (Antimony Cation (3+) - UNII:069647RPT5) Antimony Potassium Tartrate15 [hp_X]  in 1 g
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 g
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana15 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 g
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita15 [hp_X]  in 1 g
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 g
    Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh15 [hp_X]  in 1 g
    Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E) Eupatorium Perfoliatum Flowering Top15 [hp_X]  in 1 g
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum15 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 g
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 g
    Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top15 [hp_X]  in 1 g
    Lactic Acid, L- (UNII: F9S9FFU82N) (Lactic Acid, L- - UNII:F9S9FFU82N) Lactic Acid, L-15 [hp_X]  in 1 g
    Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium15 [hp_X]  in 1 g
    Strychnine (UNII: H9Y79VD43J) (Strychnine - UNII:H9Y79VD43J) Strychnine15 [hp_X]  in 1 g
    Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG) Phytolacca Americana Root3 [hp_X]  in 1 g
    Comfrey Root (UNII: M9VVZ08EKQ) (Comfrey Root - UNII:M9VVZ08EKQ) Comfrey Root3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2273-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-2273-256.7 g in 1 BOTTLE, GLASS
    3NDC:55714-2273-07.08 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-2273)
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