Indications & Usage Section
Formulated for associated symptoms such as pain, cramping, swelling, inflammation and stiffness in the legs and feet.
Leg Cramps-swelling Liquid
FDA Label NDC 55714-2473
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 Leg Cramps-swelling (NDC 55714-2473). 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. Sensitive persons begin with 1 drop and gradually increase to full dose.
Otc - Active Ingredient Section
Equal parts of Echinacea 6x, Argentum nitricum15x, Bryonia 15x, Calcarea carbonica 15x, Colocynthis 15x, Convallaria majalis 15x, Crotalus horridus 15x, Cuprum metallicum 15x, Digitalis purpurea 15x, Gelsemium sempervirens 15x, Hypericum perforatum 15x, Kali carbonicum 15x, Lachesis mutus 15x, Lathyrus sativus 15x, Lilium tigrinum 15x, Magnesia phosphorica 15x, Nux vomica 15x, Rhus toxicodendron 15x, Silicea 15x, Stramonium 15x, Veratrum viride 15x, Elaps corallinus 30x.
Otc - Purpose Section
Formulated for associated symptoms such as pain, cramping, swelling, inflammation and stiffness in the legs and feet.
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 (N048 L01)
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