Label: FIBROMYALGIA RELIEF- aconitum napellus, arsenicum album, belladonna, coniinum, gelsemium sempervirens, hypericum perforatum, kali bichromicum, lacticum acidum, phosphoricum acidum, rhus toxicodendrom, uricum acidum, 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 June 7, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENS:  Aconitum napellus 30C, Arsenicum album 30C, Belladonna 30C, Conniinum 30C, Gelsemium sempervirens 30C, Hypericum perforatum 3X, 30C, Kali bichromicum 30C, Lacticum acidum 30C, Phosphoricum acidum 30C, Rhus toxicodendron 30C, Uricum acidum 30C.


  • PURPOSE

    USES:  Temporarily relieves widespread aches, pains, and stiffness.


  • 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 (59-86F).

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United State.


  • 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 widespread aches, pains, and stiffness.


  • QUESTIONS


    Dist. by:

    The Magni Group, Inc.

    McKinney, TX 75071 USA

    www.magnilife.com

    1-800645-9199



  • PRINCIPAL DISPLAY PANEL

    MAGNILIFE

    NDC 57520-0582-1

    Homeopathic

    FIBROMYALGIA RELIEF

    For widespread Aches, Pains and Stiffness

    125 Tablets

    Fibromyalgia Relief

  • INGREDIENTS AND APPEARANCE
    FIBROMYALGIA RELIEF 
    aconitum napellus, arsenicum album, belladonna, coniinum, gelsemium sempervirens, hypericum perforatum, kali bichromicum, lacticum acidum, phosphoricum acidum, rhus toxicodendrom, uricum acidum, tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0582
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO) ARSENIC TRIOXIDE30 [hp_C]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]
    CONIINE (UNII: C479P32L2D) (CONIINE - UNII:C479P32L2D) CONIINE30 [hp_C]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_C]
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM DICHROMATE30 [hp_C]
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4) (LACTIC ACID, DL- - UNII:3B8D35Y7S4) LACTIC ACID, DL-30 [hp_C]
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID30 [hp_C]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_C]
    URIC ACID (UNII: 268B43MJ25) (URIC ACID - UNII:268B43MJ25) URIC ACID30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (round convex) Size6mm
    FlavorImprint Code diamond;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0582-1125 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/07/2011
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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