Label: DETOXIFIER- uricum acidum, benzoicum acidum, berber. vulg., bryonia, cantharis, carduus benedictus, ceanothus, chelidonium majus, chionanthus virginica, cinchona, dioscorea, dolichos, iris versicolor, juniperus com., nux vom., ptelea, taraxacum, carduus mar., cynara scolymus, solidago 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

    Detoxifier  Formulated for liver and kidney functions and for symptoms associated with toxicity such as newborn jaundice, hypersensitivity and sluggish elimination.

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) at bedtime 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

    Uricum acidum 15x, Benzoicum acidum 10x, Berber. vulg. 10x, Bryonia 10x, Cantharis 10x, Carduus benedictus 10x, Ceanothus 10x, Chelidonium majus 10x, Chionanthus virginica 10x, Cinchona 10x, Dioscorea 10x, Dolichos 10x, Iris versicolor 10x, Juniperus com. 10x, Nux vom. 10x, Ptelea 10x,Taraxacum 10x, Carduus mar. 3x, Cynara scolymus 3x, Solidago 3x,Taraxacum 3x.

  • OTC - PURPOSE SECTION

    Formulated for liver and kidney functions and for symptoms associated with toxicity such as newborn jaundice, hypersensitivity and sluggish elimination.

  • 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
    DETOXIFIER  
    uricum acidum, benzoicum acidum, berber. vulg., bryonia, cantharis, carduus benedictus, ceanothus, chelidonium majus, chionanthus virginica, cinchona, dioscorea, dolichos, iris versicolor, juniperus com., nux vom., ptelea, taraxacum, carduus mar., cynara scolymus, solidago pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Uric Acid (UNII: 268B43MJ25) (Uric Acid - UNII:268B43MJ25) Uric Acid15 [hp_X]  in 1 g
    Benzoic Acid (UNII: 8SKN0B0MIM) (Benzoic Acid - UNII:8SKN0B0MIM) Benzoic Acid10 [hp_X]  in 1 g
    Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark10 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 g
    Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria10 [hp_X]  in 1 g
    Centaurea Benedicta (UNII: 6L5ZL09795) (Centaurea Benedicta - UNII:6L5ZL09795) Centaurea Benedicta10 [hp_X]  in 1 g
    Ceanothus Americanus Leaf (UNII: 25B1Y14T8N) (Ceanothus Americanus Leaf - UNII:25B1Y14T8N) Ceanothus Americanus Leaf10 [hp_X]  in 1 g
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus10 [hp_X]  in 1 g
    Chionanthus Virginicus Bark (UNII: S9Y4B22U2E) (Chionanthus Virginicus Bark - UNII:S9Y4B22U2E) Chionanthus Virginicus Bark10 [hp_X]  in 1 g
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark10 [hp_X]  in 1 g
    Dioscorea Villosa Tuber (UNII: IWY3IWX2G8) (Dioscorea Villosa Tuber - UNII:IWY3IWX2G8) Dioscorea Villosa Tuber10 [hp_X]  in 1 g
    Mucuna Pruriens Fruit Trichome (UNII: 3E271BSI0C) (Mucuna Pruriens Fruit Trichome - UNII:3E271BSI0C) Mucuna Pruriens Fruit Trichome10 [hp_X]  in 1 g
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root10 [hp_X]  in 1 g
    Juniper Berry (UNII: O84B5194RL) (Juniper Berry - UNII:O84B5194RL) Juniper Berry10 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 g
    Ptelea Trifoliata Bark (UNII: 5KQR6FTT0D) (Ptelea Trifoliata Bark - UNII:5KQR6FTT0D) Ptelea Trifoliata Bark10 [hp_X]  in 1 g
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale10 [hp_X]  in 1 g
    Silybum Marianum Seed (UNII: U946SH95EE) (Silybum Marianum Seed - UNII:U946SH95EE) Silybum Marianum Seed3 [hp_X]  in 1 g
    Cynara Scolymus Leaf (UNII: B71UA545DE) (Cynara Scolymus Leaf - UNII:B71UA545DE) Cynara Scolymus Leaf3 [hp_X]  in 1 g
    Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-1700-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-1700-256.7 g in 1 BOTTLE, GLASS
    3NDC:55714-1700-07.08 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(55714-1700)
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