Label: HEMORRHOIDS- elaps corallinus, aesculus hipp., aloe, arsenicum alb., bryonia, calc. fluor., capsicum, collinsonia, crotalus horridus, hamamelis, hydrofluoricum acidum, hypericum, lachesis, lycopodium, millefolium, naja, nux vom., paeonia, plantago, quercus glandium spiritus, ratanhia, vipera berus, echinacea, solidago, urtica ur. pellet

  • 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

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE SECTION

    HEMORRHOIDS  Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.     

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pelles in purified water.    

  • ACTIVE INGREDIENT SECTION

    Elaps corallinus 35x, Aesculus hipp. 20x, Aloe 20x, Arsenicum alb. 20x, Bryonia 20x, Calc. fluor. 20x, Capsicum 20x, Collinsonia 20x, Crotalus horridus 20x, Hamamelis 20x, Hydrofluoricum acidum 20x, Hypericum 20x, Lachesis 20x, Lycopodium 20x, Millefolium 20x, Naja 20x, Nux vom. 20x, Paeonia 20x, Plantago 20x, Quercus glandium spiritus 20x, Ratanhia 20x, Vipera berus 20x, Aesculus hipp 8x, Echinacea 8x, Solidago 8x, Urtica ur. 8x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.         

  • PURPOSE SECTION

    Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.

  • 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
    package label
    package label

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDS  
    elaps corallinus, aesculus hipp., aloe, arsenicum alb., bryonia, calc. fluor., capsicum, collinsonia, crotalus horridus, hamamelis, hydrofluoricum acidum, hypericum, lachesis, lycopodium, millefolium, naja, nux vom., paeonia, plantago, quercus glandium spiritus, ratanhia, vipera berus, echinacea, solidago, urtica ur. pellet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4447
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom35 [hp_X]  in 1 g
    Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ) Horse Chestnut20 [hp_X]  in 1 g
    Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9) Aloe20 [hp_X]  in 1 g
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide20 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root20 [hp_X]  in 1 g
    Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O) Calcium Fluoride20 [hp_X]  in 1 g
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum20 [hp_X]  in 1 g
    Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR) Collinsonia Canadensis Root20 [hp_X]  in 1 g
    Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom20 [hp_X]  in 1 g
    Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS) (Hamamelis Virginiana Root Bark/stem Bark - UNII:T7S323PKJS) Hamamelis Virginiana Root Bark/stem Bark20 [hp_X]  in 1 g
    Hydrofluoric Acid (UNII: RGL5YE86CZ) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion20 [hp_X]  in 1 g
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum20 [hp_X]  in 1 g
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom20 [hp_X]  in 1 g
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore20 [hp_X]  in 1 g
    Achillea Millefolium (UNII: 2FXJ6SW4PK) (Achillea Millefolium - UNII:2FXJ6SW4PK) Achillea Millefolium20 [hp_X]  in 1 g
    Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom20 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed20 [hp_X]  in 1 g
    Paeonia Officinalis Root (UNII: 8R564U2E1P) (Paeonia Officinalis Root - UNII:8R564U2E1P) Paeonia Officinalis Root20 [hp_X]  in 1 g
    Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major20 [hp_X]  in 1 g
    Quercus Robur Nut (UNII: Q7MU1F4GLY) (Quercus Robur Nut - UNII:Q7MU1F4GLY) Quercus Robur Nut20 [hp_X]  in 1 g
    Krameria Lappacea Root (UNII: P29ZH1A35Z) (Krameria Lappacea Root - UNII:P29ZH1A35Z) Krameria Lappacea Root20 [hp_X]  in 1 g
    Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom20 [hp_X]  in 1 g
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified8 [hp_X]  in 1 g
    Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top8 [hp_X]  in 1 g
    Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens8 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4447-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-4447-256.7 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(55714-4447)