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

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 Item Code (Source) NDC:17312-004
    Route of Administration Oral DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 6 [hp_C]
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 6 [hp_C]
    Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum 6 [hp_C]
    Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate 6 [hp_C]
    Strychnos Nux-Vomica Seed (UNII: 269XH13919) (Strychnos Nux-Vomica Seed - UNII:269XH13919) Strychnos Nux-Vomica Seed 6 [hp_C]
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 6 [hp_C]
    Magnesium Ascorbate (UNII: 0N1G678593) (Magnesium Ascorbate - UNII:0N1G678593) Magnesium Ascorbate 200 mg
    Thiamine Hydrochloride (UNII: M572600E5P) (Thiamine Ion - UNII:4ABT0J945J) Thiamine Hydrochloride 1 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 20 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 1 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 400 ug
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 400 ug
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin 200 ug
    Calcium Pantothenate (UNII: 568ET80C3D) (Calcium Pantothenate - UNII:568ET80C3D) Calcium Pantothenate 5 mg
    Magnesium Ascorbate (UNII: 0N1G678593) (Magnesium Ascorbate - UNII:0N1G678593) Magnesium Ascorbate 75 mg
    Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Oxide - UNII:3A3U0GI71G) Magnesium Oxide 75 mg
    Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium 100 ug
    Sedum Roseum Root (UNII: 3S5ITS5ULN) (Sedum Roseum Root - UNII:3S5ITS5ULN) Sedum Roseum Root 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polyvinyl Alcohol (UNII: 532B59J990)  
    Talc (UNII: 7SEV7J4R1U)  
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Icodextrin (UNII: 2NX48Z0A9G)  
    Dextrose Monohydrate (UNII: LX22YL083G)  
    Egg Phospholipids (UNII: 1Z74184RGV)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Croscarmellose (UNII: 029TFK992N)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    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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