Label: TEMPORARY FIBROMYALGIA PAIN AND DISCOMFORT RELIEF- aconitum napellus, atropa belladonna, causticum, magnesium phosphate, dibasic trihydrate, strychnos nux-vomica seed, toxicodendron pubescens leaf, magnesium ascorbate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, magnesium ascorbate, magnesium oxide, selenium and sedum roseum root tablet, multilayer

  • 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 05/12

If you are a consumer or patient please visit this version.

  • Homeopathic Purpose

    Aconitum Napellus 6c/12c/18c Acute Pain, Inflammation
    Belladonna 6c/12c/18c Chronic Pain, Headache
    Causticum 6c/12c/18c Muscle and Nerve Pain
    Magnesium Phos 6c/12c/18c Cramping Pain, Fatigue
    Nux Vomica 6c/12c/18c Sleeplessness, Irritable bowels
    Rhus Toxicodendron 6c/12c/18c Joint and Soft Tissue Pain
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  • Active Ingredients

    Aconitum Napellus 6c/12c/18c
    Belladonna 6c/12c/18c
    Causticum 6c/12c/18c
    Magnesium Phos 6c/12c/18c
    Nux Vomica 6c/12c/18c
    Rhus Toxicodendron 6c/12c/18c
    Magnesium Ascorbate 200 mg
    Thiamine Hydrochloride 1 mg
    Riboflavin 1 mg
    Niacinamide 20 mg
    Pyridoxine Hydrochloride 1 mg
    Folic Acid 400 mcg
    Cyanocobalamin 400 mcg
    Biotin 200 mcg
    Calcium Pantothenate 5 mg
    Magnesium Ascorbate 75 mg
    Magnesium Oxide 75 mg
    Selenium 100 mcg
    Sedum Roseum Root 200 mg
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  • Inactive Ingredients

    Microcrystalline cellulose
    Polyvinyl Alcohol
    Talc
    Macrogol/PEG 3350
    Polysorbate 80
    Sodium Carboxymethylcellulose
    Dextrin
    Dextrose Monohydrate
    Lecithin
    Sodium Citrate
    Stearic Acid
    Croscarmellose
    Magnesium Stearate
    Silicon Dioxide
    Sucralose
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  • Uses

    According to homeopathic indications these ingredients provide temporary relief from symptoms of Fibromyalgia such as:

    - Muscle Pain
    - Fatigue
    - Nerve/Soft Tissue Pain
    - Headache
    - Multiple Tender Points

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  • Warnings

    - Consult with your doctor prior to use if you are pregnant or nursing.
    - Initial worsening of symptoms may occur.
    - If symptoms persist or worsen, consult your doctor.
    - Anyone experiencing widespread pain as with Fibromyalgia should see a doctor to determine if a specific treatment is needed or to make sure that it is not a sign of a serious underlying condition.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of reach of children. Close
  • Do not use

    If tamper evident seal is broken.

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  • Stop Use and See A Doctor If

    If Symptoms persist for more than 7 days or worsen or if new symptoms occur or if redness or swelling is present because these could be a sign of a serious illness.

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  • Directions

    Take 1 caplet, morning and evening, 5 minutes before or 20 minutes after a meal. Let the homeopathic external shell dissolve in your mouth until the sweetness is gone (approx. 20-40 seconds), then swallow the remaining vitamin enriched core with water. For faster results take 1 caplet 3 times per day. For best results, use for at least 6 months. After desired results are achieved, reduce dosing to 1 caplet 2 times per day.

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  • Other Information

    If an initial worsening (healing aggravation) of symptoms occurs stop use until the aggravations subsides, then continue taking the caplets.

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  • QUESTIONS

    TRP Company
    1575 Delucchi Lane #115
    Reno, NV 89502
    888-969-6855
    www.trpcompany.com

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  • INGREDIENTS AND APPEARANCE
    TEMPORARY FIBROMYALGIA PAIN AND DISCOMFORT RELIEF 
    aconitum napellus, atropa belladonna, causticum, magnesium phosphate, dibasic, strychnos nux-vomica seed, toxicodendron pubescens leaf tablet, multilayer
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17312-004
    Route of Administration Oral DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aconitum Napellus (Aconitum Napellus) Aconitum Napellus 6 [hp_C]
    Atropa Belladonna (Atropa Belladonna) Atropa Belladonna 6 [hp_C]
    Causticum (Causticum) Causticum 6 [hp_C]
    Magnesium Phosphate, Dibasic Trihydrate (Magnesium Cation) Magnesium Phosphate, Dibasic Trihydrate 6 [hp_C]
    Strychnos Nux-Vomica Seed (Strychnos Nux-Vomica Seed) Strychnos Nux-Vomica Seed 6 [hp_C]
    Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf 6 [hp_C]
    Magnesium Ascorbate (Magnesium Ascorbate) Magnesium Ascorbate 200 mg
    Thiamine Hydrochloride (Thiamine Ion) Thiamine Hydrochloride 1 mg
    Riboflavin (Riboflavin) Riboflavin 1 mg
    Niacinamide (Niacinamide) Niacinamide 20 mg
    Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 1 mg
    Folic Acid (Folic Acid) Folic Acid 400 ug
    Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 400 ug
    Biotin (Biotin) Biotin 200 ug
    Calcium Pantothenate (Calcium Pantothenate) Calcium Pantothenate 5 mg
    Magnesium Ascorbate (Magnesium Ascorbate) Magnesium Ascorbate 75 mg
    Magnesium Oxide (Magnesium Oxide) Magnesium Oxide 75 mg
    Selenium (Selenium) Selenium 100 ug
    Sedum Roseum Root (Sedum Roseum Root) Sedum Roseum Root 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    Cellulose, Microcrystalline  
    Polyvinyl Alcohol  
    Talc  
    Polyethylene Glycol 3350  
    Polysorbate 80  
    Carboxymethylcellulose Sodium  
    Icodextrin  
    Dextrose Monohydrate  
    Egg Phospholipids  
    Sodium Citrate  
    Stearic Acid  
    Croscarmellose  
    Magnesium Stearate  
    Silicon Dioxide  
    Sucralose  
    Product Characteristics
    Color white Score no score
    Shape OVAL (Tablet) Size 9mm
    Flavor Imprint Code None
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17312-004-12 1 in 1 Package
    1 60 in 1 Bottle
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 02/01/2010
    Labeler - TRP Company (105185719)
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