Label: TEMPORARY FIBROMYALGIA PAIN AND DISCOMFORT RELIEF- aconitum napellus, atropa belladonna, causticum, magnesium phosphate, dibasic, strychnos nux-vomica seed, toxicodendron pubescens leaf tablet, multilayer

  • 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 May 31, 2012

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

  • Homeopathic Purpose

    Aconitum Napellus6c/12c/18cAcute Pain, Inflammation
    Belladonna6c/12c/18cChronic Pain, Headache
    Causticum6c/12c/18cMuscle and Nerve Pain
    Magnesium Phos6c/12c/18cCramping Pain, Fatigue
    Nux Vomica6c/12c/18cSleeplessness, Irritable bowels
    Rhus Toxicodendron6c/12c/18cJoint and Soft Tissue Pain
  • Active Ingredients

    Aconitum Napellus6c/12c/18c
    Belladonna6c/12c/18c
    Causticum6c/12c/18c
    Magnesium Phos6c/12c/18c
    Nux Vomica6c/12c/18c
    Rhus Toxicodendron6c/12c/18c
    Magnesium Ascorbate200 mg
    Thiamine Hydrochloride1 mg
    Riboflavin1 mg
    Niacinamide20 mg
    Pyridoxine Hydrochloride1 mg
    Folic Acid400 mcg
    Cyanocobalamin400 mcg
    Biotin200 mcg
    Calcium Pantothenate5 mg
    Magnesium Ascorbate75 mg
    Magnesium Oxide75 mg
    Selenium100 mcg
    Sedum Roseum Root200 mg
  • 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
  • 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

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

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

    If tamper evident seal is broken.

  • 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.

  • 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.

  • Other Information

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

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Bottle image

    Box image


  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-004
    Route of AdministrationOral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus6 [hp_C]
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna6 [hp_C]
    Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum6 [hp_C]
    Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate6 [hp_C]
    Strychnos Nux-Vomica Seed (UNII: 269XH13919) (Strychnos Nux-Vomica Seed - UNII:269XH13919) Strychnos Nux-Vomica Seed6 [hp_C]
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf6 [hp_C]
    Magnesium Ascorbate (UNII: 0N1G678593) (Magnesium Ascorbate - UNII:0N1G678593) Magnesium Ascorbate200 mg
    Thiamine Hydrochloride (UNII: M572600E5P) (Thiamine Ion - UNII:4ABT0J945J) Thiamine Hydrochloride1 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride1 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid400 ug
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin400 ug
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin200 ug
    Calcium Pantothenate (UNII: 568ET80C3D) (Calcium Pantothenate - UNII:568ET80C3D) Calcium Pantothenate5 mg
    Magnesium Ascorbate (UNII: 0N1G678593) (Magnesium Ascorbate - UNII:0N1G678593) Magnesium Ascorbate75 mg
    Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Oxide - UNII:3A3U0GI71G) Magnesium Oxide75 mg
    Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium100 ug
    Sedum Roseum Root (UNII: 3S5ITS5ULN) (Sedum Roseum Root - UNII:3S5ITS5ULN) Sedum Roseum Root200 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeOVAL (Tablet) Size9mm
    FlavorImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-004-121 in 1 Package
    160 in 1 Bottle
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/01/2010
    Labeler - TRP Company (105185719)