Label: NATURAL RESPONSE- aconitum nap., arnica, arsenicum alb., bryonia, echinacea, ledum, cenchris, crotalus casc. crotalus hor., lachesis, merc. corros., naja, phos., toxicophis, vipera, elaps cor., heloderma 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 November 10, 2014

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  • INDICATIONS & USAGE SECTION

    Formulated for symptoms associated with injuries, bites and infections such as restlessness, bleeding, pain, nausea, vomiting, swelling, trembling and confusion.

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional.  Under age 2, crush/dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.  Warning:  For use as an interim therapy.  Seek professional medical intervention for severe injuries, bites or infections.

  • OTC - ACTIVE INGREDIENT SECTION

    Aconitum nap. 10x, Arnica 10x, Arsenicum alb. 10x, Bryonia 10x, Echinacea 10x, Ledum 10x, Cenchris 15x, Crotalus casc. 15x, Crotalus hor. 15x, Lachesis 15x, Merc. corros. 15x, Naja 15x, Phos. 15x, Toxicophis 15x, Vipera 15x, Elaps cor. 30x, Heloderma 30x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with injuries, bites and infections such as restlessness, bleeding, pain, nausea, vomiting, swelling, trembling and confusion.

  • 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:  Keep out of reach of children.  Do not use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a doctor before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    NATURAL RESPONSE  
    aconitum nap., arnica, arsenicum alb., bryonia, echinacea, ledum, cenchris, crotalus casc. crotalus hor., lachesis, merc. corros., naja, phos., toxicophis, vipera, elaps cor., heloderma pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2367
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus10 [hp_X]  in 1 g
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana10 [hp_X]  in 1 g
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Cation (3+)10 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 g
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified10 [hp_X]  in 1 g
    Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig10 [hp_X]  in 1 g
    Agkistrodon Contortrix Venom (UNII: 3BKX485ZP0) (Agkistrodon Contortrix Venom - UNII:3BKX485ZP0) Agkistrodon Contortrix Venom15 [hp_X]  in 1 g
    Crotalus Durissus Terrificus Venom (UNII: 2XF6I0446G) (Crotalus Durissus Terrificus Venom - UNII:2XF6I0446G) Crotalus Durissus Terrificus Venom15 [hp_X]  in 1 g
    Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom15 [hp_X]  in 1 g
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 g
    Mercuric Chloride (UNII: 53GH7MZT1R) (Mercuric Cation - UNII:ED30FJ8Y42) Mercuric Chloride15 [hp_X]  in 1 g
    Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom15 [hp_X]  in 1 g
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 g
    Agkistrodon Piscivorus Venom (UNII: X9V1Q8U150) (Agkistrodon Piscivorus Venom - UNII:X9V1Q8U150) Agkistrodon Piscivorus Venom15 [hp_X]  in 1 g
    Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom15 [hp_X]  in 1 g
    Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom30 [hp_X]  in 1 g
    Heloderma Suspectum Venom (UNII: KV57S96367) (Heloderma Suspectum Venom - UNII:KV57S96367) Heloderma Suspectum Venom30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2367-128 g in 1 BOTTLE, GLASS
    2NDC:55714-2367-257 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/10/2014
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-2367)
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