Label: MENORRHAGIA- aletris, apocynum, cinchona, cinnamomum, conium, helonias dioica, lilium, millefolium, phosphorus, secale, thlaspi, trillium pendulum, apis mel., hamamelis, hydrastis liquid

  • Category: HUMAN PRESCRIPTION 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 June 1, 2011

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  • INDICATIONS & USAGE SECTION

    Menorrhagia  Formulated for associated symptoms such as uterine fibroids, uterine polyps, endometriosis and other uterine and ovarian conditions.

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally one to four times daily or as directed by a healthcare professional.

  • ACTIVE INGREDIENT SECTION

    Aletris 15x, Apocynum 15x, Cinchona 15x, Cinnamomum 15x, Conium 15x, Helonias dioica 15x, Lilium 15x, Millefolium 15x, Phosphorus 15x, Secale 15x, Thlaspi 15x, Trillium pendulum 15x, Apis mel. 3x, Hamamelis 3x, Hydrastis 3x.

  • PURPOSE SECTION

    Formulated for associated symptoms such as uterine fibroids, uterine polyps, endometriosis and other uterine and ovarian conditions.

  • 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.

  •  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. 

  •  KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    MENORRHAGIA  
    aletris, apocynum, cinchona, cinnamomum, conium, helonias dioica, lilium, millefolium, phosphorus, secale, thlaspi, trillium pendulum, apis mel., hamamelis, hydrastis liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aletris Farinosa Root (UNII: O021JGR97X) (Aletris Farinosa Root - UNII:O021JGR97X) Aletris Farinosa Root15 [hp_X]  in 1 mL
    Apocynum Cannabinum Root (UNII: 2F92409L9Z) (Apocynum Cannabinum Root - UNII:2F92409L9Z) Apocynum Cannabinum Root15 [hp_X]  in 1 mL
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark15 [hp_X]  in 1 mL
    Cinnamon (UNII: 5S29HWU6QB) (Cinnamon - UNII:5S29HWU6QB) Cinnamon15 [hp_X]  in 1 mL
    Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top15 [hp_X]  in 1 mL
    Chamaelirium Luteum Root (UNII: DQV54Y5H3U) (Chamaelirium Luteum Root - UNII:DQV54Y5H3U) Chamaelirium Luteum Root15 [hp_X]  in 1 mL
    Lilium Lancifolium Whole Flowering (UNII: X67Z2963PI) (Lilium Lancifolium Whole Flowering - UNII:X67Z2963PI) Lilium Lancifolium Whole Flowering15 [hp_X]  in 1 mL
    Achillea Millefolium (UNII: 2FXJ6SW4PK) (Achillea Millefolium - UNII:2FXJ6SW4PK) Achillea Millefolium15 [hp_X]  in 1 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
    Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium15 [hp_X]  in 1 mL
    Capsella Bursa-pastoris (UNII: W0X9457M59) (Capsella Bursa-pastoris - UNII:W0X9457M59) Capsella Bursa-pastoris15 [hp_X]  in 1 mL
    Trillium Erectum Root (UNII: AHW6F0T2X0) (Trillium Erectum Root - UNII:AHW6F0T2X0) Trillium Erectum Root15 [hp_X]  in 1 mL
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera3 [hp_X]  in 1 mL
    Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS) (Hamamelis Virginiana Root Bark/stem Bark - UNII:T7S323PKJS) Hamamelis Virginiana Root Bark/stem Bark3 [hp_X]  in 1 mL
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4520-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-4520-259.14 mL 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(55714-4520)
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