Label: FIBROMYALGIA REAL RELIEF- calcarea phosphorica, ignatia amara, causticum, rhus toxicodendron, magnesia phosphorica, bryonia, arnica montana tablet, chewable

  • 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 November 21, 2012

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  • ACTIVE INGREDIENTS HPUS

    Calcarea phosphorica (Tribasic calcium phosphate) 7C
    Ignatia amara (Ignatius bean) 9C
    Causticum (Causticum) 7C
    Rhus toxicodendron (Poison ivy) 7C
    Magnesia phosphorica (Magnesium hydrogen phosphate) 7C
    Bryonia (White bryony) 7C
    Arnica montana (Leopard's bane) 9C


  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    fatigue, stiffness
    pain and stiffness, restless sleep
    pain and stiffness
    fatigue, pain and sleeplessness
    pain and fatigue, restless sleep
    sleeplessness, pain and stiffness
    pain and sleeplessness

  • USES

    This homeopathic medicine helps relieve symptoms associated with fibromialgia:

    - pain

    - fatigue

    - stiffness

    - insomnia

  • WARNINGS


    Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • DIRECTIONS

    Chew tablets and let dissolve in mouth.

    Do not use more than directed.

    Do not take with food.

    Repeat 3 times daily and reduce intake with improvement or as directed by a health professional.


    Age
    		 Dose
    Adults and children 12 years of age and older2 tablets
    Children under 12 years of age
    		Ask a doctor



  • OTHER INFORMATION

    Store at room temperature (68 - 77F).

    Do not use if seal is broken or missing.

  • INACTIVE INGREDIENTS

    Lactose, magnesium stearate.


  • CARTON

    image of carton label

  • INGREDIENTS AND APPEARANCE
    FIBROMYALGIA  REAL RELIEF
    calcarea phosphorica, ignatia amara, causticum, rhus toxicodendron, magnesia phosphorica, bryonia, arnica montana tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) PHOSPHATE ION7 [hp_C]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED9 [hp_C]
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM7 [hp_C]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF7 [hp_C]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION7 [hp_C]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT7 [hp_C]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA9 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-6015-090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/25/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-6015)
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