Indications & Usage Section
Leg Cramps - Swelling Formulated for associated symptoms such as pain, cramping, swelling due to inflammation, stiffness and numbness in the legs and feet.
Leg Cramps - Swelling
FDA Label NDC 55714-2295
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 55714-2295). 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 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
Otc - Active Ingredient Section
Elaps corallinus 30x, Arg. nit. 15x, Bryonia 15x, Calc. carb. 15x, Colocynthis 15x, Convallaria 15x, Crotalus horridus 15x, Cuprum met. 15x, Digitalis 15x, Gelsemium 15x, Hypericum 15x, Kali carb. 15x, Lachesis 15x, Lathyrus sativus 15x, Lilium 15x, Mag. phos. 15x, Nux vom. 15x, Rhus toxicodendron 15x, Silicea 15x, Stramonium 15x, Veratrum viride 15x, Echinacea 3x.
Otc - Purpose Section
Formulated for associated symptoms such as pain, cramping, swelling due to inflammation, stiffness and numbness in the legs and feet.
Inactive Ingredient Section
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
Questions Section
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
Warnings Section
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding Section
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Package Label
Package Label (N048 P01)
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