Label: FIBROMYALGIA REAL RELIEF- tribasic calcium phosphate, strychnos ignatii seed, causticum, toxicodendron pubescens leaf, magnesium phosphate, dibasic trihydrate, bryonia alba root and arnica montana tablet, chewable 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

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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


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  • REFERENCES

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

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  • 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

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  • USES

    This homeopathic medicine helps relieve symptoms associated with fibromialgia:

    - pain

    - fatigue

    - stiffness

    - insomnia

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  • 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.

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  • 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 older 2 tablets
    Children under 12 years of age
    Ask a doctor



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  • OTHER INFORMATION

    Store at room temperature (68 - 77F).

    Do not use if seal is broken or missing.

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  • INACTIVE INGREDIENTS

    Lactose, magnesium stearate.


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  • CARTON
  • INGREDIENTS AND APPEARANCE
    FIBROMYALGIA  REAL RELIEF
    calcarea phosphorica, ignatia amara, causticum, rhus toxicodendron, magnesia phosphorica, bryonia, arnica montana tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:60512-6015
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRIBASIC CALCIUM PHOSPHATE (PHOSPHATE ION) PHOSPHATE ION 7 [hp_C]
    STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 9 [hp_C]
    CAUSTICUM (CAUSTICUM) CAUSTICUM 7 [hp_C]
    TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 7 [hp_C]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM CATION 7 [hp_C]
    BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 7 [hp_C]
    ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 9 [hp_C]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60512-6015-0 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 07/25/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    Name Address ID/FEI Business Operations
    HOMEOLAB USA INC 202032533 manufacture(60512-6015)
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