Indications & Usage Section
Formulated for associated symptoms often related to fear, nervousness, muscle tone and trauma.
Bedwetting Pellet
FDA Label NDC 55714-1721
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Bedwetting (NDC 55714-1721). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Package Label (F044 P01)
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