Label: BEDWETTING- belladonna, cantharis, causticum, equisetum hyemale, ferrum metallicum, gelsemium, humulus, kali phos., lycopodium, nat.mur., plantago, pulsatilla, rhus aromatica, sabal, thyroidinum, verbascum, echinacea, hydrastis, passiflora, valeriana 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

    Bedwetting    Formulated for associated symptoms often related to fear, nervousness, muscle tone, trauma and bladder weakness.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) one hour before bedtime, and then again at bedtime. Repeat 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

    Belladonna 15x, Cantharis 15x ,Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium 15x, Humulus 15x, Kali phos. 15x, Lycopodium 15x, Nat.mur. 15x, Plantago 15x, Pulsatilla 15x, Rhus aromatica 15x,Sabal 15x, Thyroidinum 15x, Verbascum 15x, Echinacea 3x, Hydrastis 3x, Passiflora 3x, Valeriana 3x.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms often related to fear, nervousness, muscle tone, trauma and bladder weakness.

  • 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
    BEDWETTING  
    belladonna, cantharis, causticum, equisetum hyemale, ferrum metallicum, gelsemium, humulus, kali phos., lycopodium, nat.mur., plantago, pulsatilla, rhus aromatica, sabal, thyroidinum, verbascum, echinacea, hydrastis, passiflora, valeriana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1513
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [hp_X]  in 1 mL
    Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria15 [hp_X]  in 1 mL
    Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum15 [hp_X]  in 1 mL
    Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale15 [hp_X]  in 1 mL
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron15 [hp_X]  in 1 mL
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root15 [hp_X]  in 1 mL
    Hops (UNII: 01G73H6H83) (Hops - UNII:01G73H6H83) Hops15 [hp_X]  in 1 mL
    Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Phosphate Ion - UNII:NK08V8K8HR) Potassium Phosphate, Dibasic15 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
    Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride15 [hp_X]  in 1 mL
    Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major15 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
    Rhus Aromatica Root Bark (UNII: Q3H36W0J42) (Rhus Aromatica Root Bark - UNII:Q3H36W0J42) Rhus Aromatica Root Bark15 [hp_X]  in 1 mL
    Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto15 [hp_X]  in 1 mL
    Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P) Thyroid, Unspecified15 [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
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 mL
    Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top3 [hp_X]  in 1 mL
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-1513-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-1513-259.14 mL in 1 BOTTLE, GLASS
    3NDC:55714-1513-0.5 mL 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(55714-1513)
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