Label: FEMALE FIBROIDS- arsenicum alb., clacarea iodata, carbo animalis, conium, graphites, hydrastis, iodium, kreosotum, lachesis, phosphorus, sabina, secale, sepia, silicea, thlaspi, thuja occ., thyroidinum, trillium pendulum, ustilago maidis pellet

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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 1, 2011

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  • INDICATIONS & USAGE SECTION

    FEMALE FIBROIDS  Formulated for symptoms associated with non-malignant uterine or ovarian fibroids, ovarian or vaginal cysts and uterine polyps.      

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Ages 12 and up, take 6 pellets orally one to four times daily or as directed by a healthcare professional.      

  • ACTIVE INGREDIENT SECTION

    Arsenicum alb. 15x, Calcarea iodata 15x, Carbo animalis 15x, Conium 15x, Graphites 15x, Hydrastis 15x,  Iodium 15x, Kreosotum 15x, Lachesis 15x, Phosphorus 15x, Sabina 15x, Secale 15x, Sepia 15x, Silicea 15x, Thlaspi  15x, Thuja occ. 15x, Thyroidinum 15x, Trillium pendulum 15x, Ustilago maidis 15x, Hydrastis 3x, Thuja occ. 3x.          

  • PURPOSE SECTION

    Formulated for symptoms associated with non-malignant uterine or ovarian fibroids, ovarian or vaginal cysts and uterine polyps.

  • 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.     

  • PREGNANCY OR BREAST FEEDING SECTION

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

  • KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.           

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    FEMALE FIBROIDS  
    arsenicum alb., clacarea iodata, carbo animalis, conium, graphites, hydrastis, iodium, kreosotum, lachesis, phosphorus, sabina, secale, sepia, silicea, thlaspi, thuja occ., thyroidinum, trillium pendulum, ustilago maidis pellet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4593
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 g
    Calcium Iodide (UNII: 8EKI9QEE2H) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Iodide15 [hp_X]  in 1 g
    Carbo Animalis (UNII: 279O8I0433) (Carbo Animalis - UNII:279O8I0433) Carbo Animalis15 [hp_X]  in 1 g
    Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top15 [hp_X]  in 1 g
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite15 [hp_X]  in 1 g
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal15 [hp_X]  in 1 g
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine15 [hp_X]  in 1 g
    Wood Creosote (UNII: 3JYG22FD73) (Wood Creosote - UNII:3JYG22FD73) Wood Creosote15 [hp_X]  in 1 g
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 g
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 g
    Juniperus Sabina Leafy Twig (UNII: Z5BEX9K2G1) (Juniperus Sabina Leafy Twig - UNII:Z5BEX9K2G1) Juniperus Sabina Leafy Twig15 [hp_X]  in 1 g
    Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium15 [hp_X]  in 1 g
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 g
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide15 [hp_X]  in 1 g
    Capsella Bursa-pastoris (UNII: W0X9457M59) (Capsella Bursa-pastoris - UNII:W0X9457M59) Capsella Bursa-pastoris15 [hp_X]  in 1 g
    Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig15 [hp_X]  in 1 g
    Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P) Thyroid, Unspecified15 [hp_X]  in 1 g
    Trillium Erectum Root (UNII: AHW6F0T2X0) (Trillium Erectum Root - UNII:AHW6F0T2X0) Trillium Erectum Root15 [hp_X]  in 1 g
    Ustilago Maydis (UNII: 4K7Z7K7SWG) (Ustilago Maydis - UNII:4K7Z7K7SWG) Ustilago Maydis15 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4593-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-4593-256.7 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-4593)
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