Label: RESTLESS LEGS RELIEF- gnaphalium polycephalum, viscum album, aconitum napellus, ledum palustre, magnesia phosphorica, rhus toxicodendron, tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 16, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Gnaphalium polycephalum 4X, Viscum album 4X, Aconitum napellus 6X, Ledum palustre 6X, Magnesia phosphorica 6X, Rhus toxicodendron 6X.

  • 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.

  • 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.

  • QUESTIONS


    Dist. by:

    The Magni Group, Inc.

    McKinney, TX 75070 USA

    www.magnilife.com

    1-800-645-9199



  • PRINCIPAL DISPLAY PANEL

    MAGNILIFE

    NDC 57520-0424-1

    Homeopathic

    RESTLESS LEGS RELIEF

    For Uncontrollable Urges to Move the Legs

    125 Tablets

    Restless Legs Relief

  • INGREDIENTS AND APPEARANCE
    RESTLESS LEGS RELIEF 
    gnaphalium polycephalum, viscum album, aconitum napellus, ledum palustre, magnesia phosphorica, rhus toxicodendron, tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0424
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM4 [hp_X]
    VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 4 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG6 [hp_X]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (round) Size6mm
    FlavorImprint Code diamond
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0424-1125 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/16/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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