Otc - Active Ingredient
ACTIVE INGREDIENTS: Gnaphalium polycephalum 4X, Viscum album 4X, Aconitum napellus 6X, Ledum palustre 6X, Magnesia phosphorica 6X, Rhus toxicodendron 6X.
Restless Legs Relief
FDA Label NDC 57520-0424
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Restless Legs Relief (NDC 57520-0424). 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 otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
USES: Temporarily relieves uncomfortable sensations in the legs that urge one to move during periods of inactivity, such as sleep.
Warnings
WARNINGS: If pregnant or breastfeeding, 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.
OTHER INFORMATION: Tamper Sealed: Sealed for your protection. Do not use if seal is broken or missing.
Store tightly closed in a cool, dry place. (59-86 degrees f).
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
Dosage & Administration
DIRECTIONS: Adults and children 12 years and above: Dissolve 2 tablets under tongue 2 to 3 times daily or as directed by a physician.
Children under 12 years: Consult a physician.
Inactive Ingredient
INACTIVE INGREDIENTS: Lactose, Magnesium stearate, Microcrystalline cellulose.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
Indications & Usage
USES: Temporarily relieves uncomfortable sensations in the legs that urge one to move during periods of inactivity, such as sleep.
Otc - Questions
Dist. by:
The Magni Group, Inc.
McKinney, TX 75070 USA
www.magnilife.com
1-800-645-9199
Package Label.Principal Display Panel
MAGNILIFE
NDC 57520-0424-1
Homeopathic
RESTLESS LEGS RELIEF
For Uncontrollable Urges to Move the Legs
125 Tablets
Restless Legs Relief (Mm1)
* Please review the disclaimer below.
