Active Ingredient:
(in each tablet) Arsenicum Album 12X 0.0143%, Causticum 12X 0.0143%, Chamomilla 6X 0.0143%, Lycopodium Clavatum 6X 0.0143%, Palladium Metallicum 12X 0.0143%, Platinum Metallicum 12X 0.0143%, Zincum Metallicum 12X 0.0143%.
Restless Legs Tablet
FDA Label NDC 70163-0006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naturalcare for the product Restless Legs (NDC 70163-0006). 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 active ingredient:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Arsenicum Album – desire to move feet constantly, Causticum – restless legs at night, Chamomilla – urge to get up and walk around, Lycopodium Clavatum – weakness, numbness, let cramps, Palladium Metallicum – heavy limbs, darting pains, restlessness, Platinum Metallicum – restlessness, tingling legs, Zincum Metallicum – twitching and jerking of legs*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Uses:
May help temporarily relieve ■ leg sensations like tingling, twitching, crawling, cramps
■ restlessness of legs and feet ■ the urge to move and walk around*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings:
Stop and ask a doctor if
■ symptoms worsen or persist for more than 7 days
■ new symptoms appear
■ redness or swelling are present
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if printed foil blister is broken or missing.
■ Store at room temperature (65-80°F)
Keep Out Of Reach Of Children:
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
Adults and children 12 years and over:
■ take 1 tablet every 4 hours as needed.
Inactive Ingredients:
croscarmellose sodium, dextrose, lactose, magnesium stearate, microcrystalline cellulose
Questions:
Dist. By NaturalCare
201 Apple Blvd.
Woodbine, IA 51579
www.NaturalCareWorks.com
1-888-280-5672
Package Label Display:
NaturalCare
Restless Legs
Homeopathic
For Relief of*
Jerking & Twitching Legs
Restless Legs at Night
Tingling Legs
60 Tablets
* Please review the disclaimer below.
