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

Bedwetting by

Drug Labeling and Warnings

Bedwetting by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-1713
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H)	Atropa Belladonna	15 [hp_X]  in 1 g
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT)	Lytta Vesicatoria	15 [hp_X]  in 1 g
Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU)	Causticum	15 [hp_X]  in 1 g
Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25)	Equisetum Hyemale	15 [hp_X]  in 1 g
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	15 [hp_X]  in 1 g
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q)	Gelsemium Sempervirens Root	15 [hp_X]  in 1 g
Hops (UNII: 01G73H6H83) (Hops - UNII:01G73H6H83)	Hops	15 [hp_X]  in 1 g
Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Phosphate Ion - UNII:NK08V8K8HR)	Potassium Phosphate, Dibasic	15 [hp_X]  in 1 g
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479)	Lycopodium Clavatum Spore	15 [hp_X]  in 1 g
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698)	Sodium Chloride	15 [hp_X]  in 1 g
Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U)	Plantago Major	15 [hp_X]  in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV)	Pulsatilla Vulgaris	15 [hp_X]  in 1 g
Rhus Aromatica Root Bark (UNII: Q3H36W0J42) (Rhus Aromatica Root Bark - UNII:Q3H36W0J42)	Rhus Aromatica Root Bark	15 [hp_X]  in 1 g
Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS)	Saw Palmetto	15 [hp_X]  in 1 g
Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P)	Thyroid, Unspecified	15 [hp_X]  in 1 g
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172)	Verbascum Thapsus	15 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX)	Echinacea, Unspecified	3 [hp_X]  in 1 g
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV)	Goldenseal	3 [hp_X]  in 1 g
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O)	Passiflora Incarnata Flowering Top	3 [hp_X]  in 1 g
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW)	Valerian	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sucrose (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-1713-1	28.35 g in 1 BOTTLE, GLASS
2	NDC: 55714-1713-2	56.7 g in 1 BOTTLE, GLASS
3	NDC: 55714-1713-0	7.08 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-1713)