Label: THROAT CARE- aconitum nap., apis mel., arum dracontium, belladonna, bryonia, cajuputum, ferrum phosphoricum, glycyrrhiza glabra, kali bic., lachesis, mentha piperita, merc. viv., naja, nat. carb., nat. sulphuricum, nitricum ac., nux vom., phosphorus, phytolacca, pulsatilla, spongia, stannum met., sticta, thuja occ., ulmus fulva, verbascum, echinacea 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 March 1, 2011

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  • INDICATIONS & USAGE SECTION

    Throat Care  Formulated for symptoms associated with throat conditions such as dryness, irritation, inflammation, pain and hoarseness.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Aconitum nap. 15x, Apis mel. 15x, Arum dracontium 15x, Belladonna 15x, Bryonia 15x, Cajuputum 15x, Ferrum phosphoricum 15x, Glycyrrhiza glabra 15x, Kali bic.15x, Lachesis 15x, Mentha piperita 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Nitricum ac. 15x, Nux vom.15x, Phosphorus 15x, Phytolacca 15x, Pulsatilla 15x, Spongia 15x, Stannum met. 15x, Sticta 15x, Thuja occ. 15x, Ulmus fulva 15x, Verbascum 15x, Echinacea 3x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with throat conditions such as dryness, irritation, inflammation, pain and hoarseness.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

  • 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
    THROAT CARE  
    aconitum nap., apis mel., arum dracontium, belladonna, bryonia, cajuputum, ferrum phosphoricum, glycyrrhiza glabra, kali bic., lachesis, mentha piperita, merc. viv., naja, nat. carb., nat. sulphuricum, nitricum ac., nux vom., phosphorus, phytolacca, pulsatilla, spongia, stannum met., sticta, thuja occ., ulmus fulva, verbascum, echinacea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2248
    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 mL
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera15 [hp_X]  in 1 mL
    Arisaema Dracontium Root (UNII: 73BHJ429FF) (Arisaema Dracontium Root - UNII:73BHJ429FF) Arisaema Dracontium Root15 [hp_X]  in 1 mL
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Cajuput Oil (UNII: J3TO6BUQ37) (Cajuput Oil - UNII:J3TO6BUQ37) Cajuput Oil15 [hp_X]  in 1 mL
    Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate15 [hp_X]  in 1 mL
    Glycyrrhiza Glabra (UNII: 2788Z9758H) (Glycyrrhiza Glabra - UNII:2788Z9758H) Glycyrrhiza Glabra15 [hp_X]  in 1 mL
    Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate15 [hp_X]  in 1 mL
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 mL
    Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9) Mentha Piperita15 [hp_X]  in 1 mL
    Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury15 [hp_X]  in 1 mL
    Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom15 [hp_X]  in 1 mL
    Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D) Sodium Carbonate15 [hp_X]  in 1 mL
    Sodium Sulfate (UNII: 0YPR65R21J) (Sodium Sulfate Anhydrous - UNII:36KCS0R750) Sodium Sulfate15 [hp_X]  in 1 mL
    Nitric Acid (UNII: 411VRN1TV4) (Nitric Acid - UNII:411VRN1TV4) Nitric Acid15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
    Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG) Phytolacca Americana Root15 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
    Spongia Officinalis Skeleton, Roasted (UNII: 1PIP394IID) (Spongia Officinalis Skeleton, Roasted - UNII:1PIP394IID) Spongia Officinalis Skeleton, Roasted15 [hp_X]  in 1 mL
    Tin (UNII: 387GMG9FH5) (Tin - UNII:387GMG9FH5) Tin15 [hp_X]  in 1 mL
    Lobaria Pulmonaria (UNII: D1YM0P5Z2T) (Lobaria Pulmonaria - UNII:D1YM0P5Z2T) Lobaria Pulmonaria15 [hp_X]  in 1 mL
    Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig15 [hp_X]  in 1 mL
    Ulmus Rubra Bark (UNII: 91QY4PXU8Q) (Ulmus Rubra Bark - UNII:91QY4PXU8Q) Ulmus Rubra Bark15 [hp_X]  in 1 mL
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus15 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2248-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-2248-259.14 mL in 1 BOTTLE, GLASS
    3NDC:55714-2248-0.5 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-2248)
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