Bedwetting

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:39:24

Label at a glance#

ProductBedwetting

Active ingredientAtropa Belladonna, Lytta Vesicatoria, Causticum, Equisetum Hyemale, Iron, Gelsemium Sempervirens Root, Hops, Potassium Phosphate, Dibasic, Lycopodium Clavatum Spore, Sodium Chloride, Plantago Major, Pulsatilla Vulgaris, Rhus Aromatica Root Bark, Saw Palmetto, Thyroid, Unspecified, Verbascum Thapsus, Echinacea, Unspecified, Goldenseal, Passiflora Incarnata Flowering Top, Valerian

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

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

OTC - 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.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-1713-0	2020-01-31	C162847	48780-1	9d75b9d0-57f4-f424-e053-dadaa90a57ce	Bedwetting
55714-1713-1	2020-01-31	C162847	48780-1	9d75b9d0-57f4-f424-e053-dadaa90a57ce	Bedwetting
55714-1713-2	2020-01-31	C162847	48780-1	9d75b9d0-57f4-f424-e053-dadaa90a57ce	Bedwetting

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-1713	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.]	1	Legacy NDC	20131024_4f9cb2c5-e9f1-bf51-8603-a712abffb670.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Atropa Belladonna	ACTIVE INGREDIENT	WQZ3G9PF0H	1
Causticum	ACTIVE INGREDIENT	DD5FO1WKFU	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Equisetum Hyemale	ACTIVE INGREDIENT	59677RXH25	1
Gelsemium Sempervirens Root	ACTIVE INGREDIENT	639KR60Q1Q	1
Goldenseal	ACTIVE INGREDIENT	ZW3Z11D0JV	1
Hops	ACTIVE INGREDIENT	01G73H6H83	1
Iron	ACTIVE INGREDIENT	E1UOL152H7	1
Lycopodium Clavatum Spore	ACTIVE INGREDIENT	C88X29Y479	1
Lytta Vesicatoria	ACTIVE INGREDIENT	3Q034RO3BT	1
Passiflora Incarnata Flowering Top	ACTIVE INGREDIENT	CLF5YFS11O	1
Plantago Major	ACTIVE INGREDIENT	W2469WNO6U	1
Potassium Phosphate, Dibasic	ACTIVE INGREDIENT	CI71S98N1Z	1
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	1
Rhus Aromatica Root Bark	ACTIVE INGREDIENT	Q3H36W0J42	1
Saw Palmetto	ACTIVE INGREDIENT	J7WWH9M8QS	1
Sodium Chloride	ACTIVE INGREDIENT	451W47IQ8X	1
Thyroid, Unspecified	ACTIVE INGREDIENT	0B4FDL9I6P	1
Valerian	ACTIVE INGREDIENT	JWF5YAW3QW	1
Verbascum Thapsus	ACTIVE INGREDIENT	C9TD27U172	1
Atropa Belladonna	ACTIVE MOIETY	WQZ3G9PF0H	1
Causticum	ACTIVE MOIETY	DD5FO1WKFU	1
Chloride Ion	ACTIVE MOIETY	Q32ZN48698	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Equisetum Hyemale	ACTIVE MOIETY	59677RXH25	1
Gelsemium Sempervirens Root	ACTIVE MOIETY	639KR60Q1Q	1
Goldenseal	ACTIVE MOIETY	ZW3Z11D0JV	1
Hops	ACTIVE MOIETY	01G73H6H83	1
Iron	ACTIVE MOIETY	E1UOL152H7	1
Lycopodium Clavatum Spore	ACTIVE MOIETY	C88X29Y479	1
Lytta Vesicatoria	ACTIVE MOIETY	3Q034RO3BT	1
Passiflora Incarnata Flowering Top	ACTIVE MOIETY	CLF5YFS11O	1
Phosphate Ion	ACTIVE MOIETY	NK08V8K8HR	1
Plantago Major	ACTIVE MOIETY	W2469WNO6U	1
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	1
Rhus Aromatica Root Bark	ACTIVE MOIETY	Q3H36W0J42	1
Saw Palmetto	ACTIVE MOIETY	J7WWH9M8QS	1
Thyroid, Unspecified	ACTIVE MOIETY	0B4FDL9I6P	1
Valerian	ACTIVE MOIETY	JWF5YAW3QW	1
Verbascum Thapsus	ACTIVE MOIETY	C9TD27U172	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

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
Atropa Belladonna
Lytta Vesicatoria
Causticum
Equisetum Hyemale
Iron
Gelsemium Sempervirens Root
Hops
Potassium Phosphate, Dibasic
Phosphate Ion
Lycopodium Clavatum Spore
Sodium Chloride
Chloride Ion
Plantago Major
Pulsatilla Vulgaris
Rhus Aromatica Root Bark
Saw Palmetto
Thyroid, Unspecified
Verbascum Thapsus
Echinacea, Unspecified
Goldenseal
Passiflora Incarnata Flowering Top
Valerian
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-1713	55714-1713-1, 55714-1713-2, 55714-1713-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Atropa Belladonna	WQZ3G9PF0H	ACTIB
Lytta Vesicatoria	3Q034RO3BT	ACTIB
Causticum	DD5FO1WKFU	ACTIB
Equisetum Hyemale	59677RXH25	ACTIB
Iron	E1UOL152H7	ACTIB
Gelsemium Sempervirens Root	639KR60Q1Q	ACTIB
Hops	01G73H6H83	ACTIB
Potassium Phosphate, Dibasic	CI71S98N1Z	ACTIB
Lycopodium Clavatum Spore	C88X29Y479	ACTIB
Sodium Chloride	451W47IQ8X	ACTIB
Plantago Major	W2469WNO6U	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Rhus Aromatica Root Bark	Q3H36W0J42	ACTIB
Saw Palmetto	J7WWH9M8QS	ACTIB
Thyroid, Unspecified	0B4FDL9I6P	ACTIB
Verbascum Thapsus	C9TD27U172	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Goldenseal	ZW3Z11D0JV	ACTIB
Passiflora Incarnata Flowering Top	CLF5YFS11O	ACTIB
Valerian	JWF5YAW3QW	ACTIB
Sucrose	C151H8M554	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4e59cd4e-2e61-b3e2-e063-6394a90acb23			4f9cb2c5-e9f1-bf51-8603-a712abffb670	2026-03-31	Warnings	Exact identifier spl set id: 4f9cb2c5-e9f1-bf51-8603-a712abffb670

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.