Bedwetting
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2025-07-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:34:32
Label at a glance#
ProductBedwetting
Active ingredientECHINACEA, UNSPECIFIED, VALERIAN, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, EQUISETUM HYEMALE, IRON, GELSEMIUM SEMPERVIRENS ROOT, HOPS, DIBASIC POTASSIUM PHOSPHATE, GOLDENSEAL, SODIUM CHLORIDE, PLANTAGO MAJOR, ANEMONE PULSATILLA, TOXICODENDRON PUBESCENS LEAF, SAW PALMETTO, THYROID, UNSPECIFIED, VERBASCUM THAPSUS, PASSIFLORA INCARNATA FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for symptoms of nighttime incontinence 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
USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
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 drops by mouth (ages 12 and up, give 6 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a health professioal. Sensitive person begin with 1 drop and gradually increase to full dose.
PACKAGE LABEL
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-1521-1 | Bedwetting | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 3 |
Products#
Every source-derived product name is available through these pages.
- 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
- ECHINACEA, UNSPECIFIED
- ALCOHOL
- WATER
- VALERIAN
- ATROPA BELLADONNA
- LYTTA VESICATORIA
- CAUSTICUM
- EQUISETUM HYEMALE
- IRON
- GELSEMIUM SEMPERVIRENS ROOT
- HOPS
- DIBASIC POTASSIUM PHOSPHATE
- POTASSIUM CATION
- GOLDENSEAL
- SODIUM CHLORIDE
- SODIUM CATION
- PLANTAGO MAJOR
- ANEMONE PULSATILLA
- TOXICODENDRON PUBESCENS LEAF
- SAW PALMETTO
- THYROID, UNSPECIFIED
- VERBASCUM THAPSUS
- PASSIFLORA INCARNATA FLOWERING TOP
- LYCOPODIUM CLAVATUM SPORE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-1521 | 55714-1521-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Newton Laboratories, Inc. | 9d5f51d0-01e9-271c-e053-2995a90a63bc | 2025-07-24 | Warnings | 55714-1521-1 55714-1521 55714152101 3ab08f82-2c8b-2374-e063-6294a90a6a22 9d5f51d0-01e9-271c-e053-2995a90a63bc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.