Otc - Active Ingredient
ACTIVE INGREDIENTS: Aconitum napellus 6X, Gnaphalium polycephalum 4X, Ledum palustre 6X, Magnesia phosphorica 6X, Rhus toxicodendron 6X, Viscum album 4X.
Restless Legs Relief
FDA Label NDC 57520-0450
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 57520-0450). 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: Restless Legs Relief homeopathic formula helps relieve the unpleasant sensations that urge you to move your legs during periods of rest.
Warnings
WARNINGS: Use only as directed.
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.
Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing.
Other Information: Store tightly closed in a cool dry place (59 to 86 F)
Dosage & Administration
DIRECTIONS: Adults dissolve 2 tablets under tongue twice a day.
Can be increased to 2 tablets 3 times a day, if needed.
For stubborn cases, take 1-2 tablets every 4 hours.
For children 12 and under, consult a health professional.
For maximum effectiveness, take tablets regularly and consistently.
Regular use will generally result in a positive effect within 4-6 weeks, although many people respond even sooner.
Inactive Ingredient
INACTIVE INGREDIENTS: Lactose, Magnesium stearate, Mycrocrystalline 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: Restless Legs Relief homeopathic formula helps relieve the unpleasant sensations that urge you to move your legs during periods of rest.
Otc - Questions
Questions or Comments? 800-645-9199
The Magni Group, Inc.
McKinney, TX 75070 USA
www.magnilife.com
Package Label.Principal Display Panel
MagniLife
RESTLESS LEGS RELIEF
100% Homeopathic Formulation
Calm Relax Relieve Ease Soothe
100 Tablets
Restless Legs Relief (Mm1)
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