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 pellet 
Newton Laboratories, Inc.

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.

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Bedwetting

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:  Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed 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

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: 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

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 pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1713
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 g
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria15 [hp_X]  in 1 g
Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum15 [hp_X]  in 1 g
Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale15 [hp_X]  in 1 g
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron15 [hp_X]  in 1 g
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root15 [hp_X]  in 1 g
Hops (UNII: 01G73H6H83) (Hops - UNII:01G73H6H83) Hops15 [hp_X]  in 1 g
Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Phosphate Ion - UNII:NK08V8K8HR) Potassium Phosphate, Dibasic15 [hp_X]  in 1 g
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 g
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride15 [hp_X]  in 1 g
Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major15 [hp_X]  in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 g
Rhus Aromatica Root Bark (UNII: Q3H36W0J42) (Rhus Aromatica Root Bark - UNII:Q3H36W0J42) Rhus Aromatica Root Bark15 [hp_X]  in 1 g
Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto15 [hp_X]  in 1 g
Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P) Thyroid, Unspecified15 [hp_X]  in 1 g
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus15 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 g
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 g
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top3 [hp_X]  in 1 g
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-1713-128.35 g in 1 BOTTLE, GLASS
2NDC:55714-1713-256.7 g in 1 BOTTLE, GLASS
3NDC:55714-1713-07.08 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(55714-1713)

Revised: 3/2011
Document Id: 13c1764a-6fa3-af12-79bf-96d99b1afb45
Set id: 4f9cb2c5-e9f1-bf51-8603-a712abffb670
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.