BEDWETTING- echinacea, hydrastis canadensis, passiflora incarnata, valeriana officinalis, belladonna, cantharis, causticum, equisetum hyemale, ferrum metallicum, gelsemium sempervirens, humulus lupulus, kali phosphoricum, lycopodium clavatum, natrum muriaticum, plantago major, pulsatilla, rhus aromatica, sabal serrulata, thyroidinum, verbascum thapsus 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

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Passiflora incarnata 6x, Valeriana officinalis 6x, Belladonna 15x, Cantharis 15x, Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium sempervirens 15x, Humulus lupulus 15x, Kali phosphoricum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Plantago major 15x, Pulsatilla 15x, Rhus aromatica 15x, Sabal serrulata 15x, Thyroidinum 15x, Verbascum thapsus 15x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a health professioal. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

BEDWETTING 
echinacea, hydrastis canadensis, passiflora incarnata, valeriana officinalis, belladonna, cantharis, causticum, equisetum hyemale, ferrum metallicum, gelsemium sempervirens, humulus lupulus, kali phosphoricum, lycopodium clavatum, natrum muriaticum, plantago major, pulsatilla, rhus aromatica, sabal serrulata, thyroidinum, verbascum thapsus pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-1721
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X]  in 1 g
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X]  in 1 g
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
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152)	DIBASIC POTASSIUM PHOSPHATE	15 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	15 [hp_X]  in 1 g
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	15 [hp_X]  in 1 g
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	15 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	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
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [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: 55714-1721-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-1721)