Label: HENDEL FIBROMYALGIA SYMPTOM RELIEF- valerian, arnica montana root, aconitum napellus, bryonia alba root,toxicodendron pubescens leaf, berberis vulgaris root bark, colchicum autumnale bulb, solanum dulcamara top, harpagophytum procumbens whole, rhododendron tomentosum leafy twig, and rhododendron aureum leaf tablet

  • Category: HUMAN OTC DRUG LABEL

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 April 17, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • WARNINGS

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Fibromyalgia Symptom Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS

    Fibromyalgia Symptom Relief

  • INGREDIENTS

    Each tablet contains equal parts of Valeriana officinalis 2X; Arnica montana,radix 3X, 6X; Aconitum napellus 4X; Bryonia4X; Rhus tox 4X, 8X, 12X, 30X; Berberis vulgaris 6X; Colchicum autumnale 6X; Dulcamara6X, Harpagophytum 6X; Ledum palustre 6X; Rhododendron chrysanthum 6X

  • INACTIVE INGREDIENT

    Lactose, Magnesium stearate

  • DIRECTIONS

    Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician

  • USES

    For the temporary relief of:

    • Fatigue
    • Muscle Pain
    • Sleeplessness

  • PRINCIPAL DISPLAY PANEL

    Hendel Fibromyalgia Symptom Relief.jpg

  • INGREDIENTS AND APPEARANCE
    HENDEL FIBROMYALGIA SYMPTOM RELIEF 
    valerian, arnica montana root, aconitum napellus, bryonia alba root,toxicodendron pubescens leaf, berberis vulgaris root bark, colchicum autumnale bulb, solanum dulcamara top, harpagophytum procumbens whole, rhododendron tomentosum leafy twig, and rhododendron aureum leaf tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN2 [hp_X]
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF4 [hp_X]
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB6 [hp_X]
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP6 [hp_X]
    HARPAGOPHYTUM PROCUMBENS WHOLE (UNII: BY51E8JN4B) (HARPAGOPHYTUM PROCUMBENS WHOLE - UNII:BY51E8JN4B) HARPAGOPHYTUM PROCUMBENS WHOLE6 [hp_X]
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG6 [hp_X]
    RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code LEAFMAN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-1117-2100 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2016
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-1117)