Indications & Usage Section
Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.
Restless Leg Liquid
FDA Label NDC 55714-4787
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 Restless Leg (NDC 55714-4787). 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, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration Section
Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.
Otc - Active Ingredient Section
Equal parts of Chamomilla 6x, Passiflora incarnata 6x, Valeriana officinalis 6x, Agaricus muscarius 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Cuprum metallicum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Hypericum perforatum 15x, Kali carbonicum 15x, Magnesia carbonica 15x, Mercurius vivus 15x, Nux vomica 15x, Plumbum metallicum 15x, Rhus toxicodendron 15x, Secale cornutum 15x, Strychninum 15x, Tarentula hispana 15x, Valeriana officinalis 15x, Verbascum thapsus 15x, Zincum metallicum 15x, Mygale 16x.
Otc - Purpose Section
Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.
Inactive Ingredient Section
Inactive Ingredients: 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
Package Label
Package Label (R117 L01)
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