Bedwetting 1721p

Bedwetting 1721p
SPL v3
SPL
SPL Set ID 9d6058a0-69dd-66d0-e053-2a95a90a58f8
Route
ORAL
Published
Effective Date 2025-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea, Unspecified (6 [hp_X]) Valerian (15 [hp_X]) Atropa Belladonna Lytta Vesicatoria Causticum Equisetum Hyemale Iron Gelsemium Sempervirens Root Hops Potassium Cation Goldenseal Sodium Cation Plantago Major Anemone Pulsatilla Toxicodendron Pubescens Leaf Saw Palmetto Thyroid, Unspecified Verbascum Thapsus Passiflora Incarnata Flowering Top Lycopodium Clavatum Spore
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

Formulated for symptoms of nighttime incontinence often related to fear, nervousness, muscle tone and trauma.

Purpose

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


Medication Information

Purpose

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

Description

Formulated for symptoms of nighttime incontinence often related to fear, nervousness, muscle tone and trauma.

Package Label

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.

Questions Section

newtonlabs.net – Questions? 800.448.7256

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

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

Indications & Usage Section

Formulated for symptoms of nighttime incontinence often related to fear, nervousness, muscle tone and trauma.

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.

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 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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

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

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms of nighttime incontinence often related to fear, nervousness, muscle tone and trauma.

Dosage & Administration Section (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.

Otc Active Ingredient Section (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 Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)