Temporary Fibromyalgia Pain and Discomfort Relief

Manufacturer
TRP Company
Effective date
2012-05-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:48

Label at a glance#

ProductTemporary Fibromyalgia Pain and Discomfort Relief
Active ingredientAconitum 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 Oxide, Selenium, Sedum Roseum Root
Label structure12 sections

Indications and 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

Dosage and administration

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...

Label contents#

Full prescribing information#

Homeopathic Purpose

OTC - PURPOSE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

- 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children.

Do not use

OTC - DO NOT USE SECTION

If tamper evident seal is broken.

Stop Use and See A Doctor If

OTC - STOP USE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle image
Bottle image

Box image
Box image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17312-004-122019-11-13C16284748780-197449f38-c4ee-f6ea-e053-dbdaa90aa703Temporary Fibromyalgia Pain and Discomfort Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17312-004-12Temporary Fibromyalgia Pain and Discomfort Relief1 in 1 PackageTablet, Multilayer11
17312-004-12Temporary Fibromyalgia Pain and Discomfort Relief60 in 1 BottleTablet, Multilayer601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17312-004TEMPORARY FIBROMYALGIA PAIN AND DISCOMFORT RELIEF (ACONITUM NAPELLUS, ATROPA BELLADONNA, CAUSTICUM, MAGNESIUM PHOSPHATE, DIBASIC, STRYCHNOS NUX-VOMICA SEED, TOXICODENDRON PUBESCENS LEAF) TABLET, MULTILAYER [TRP COMPANY]1Legacy NDC, 2 package rows20120605_922107dd-bb24-4efe-b034-8296404da720.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
BiotinACTIVE INGREDIENT6SO6U10H041
Calcium PantothenateACTIVE INGREDIENT568ET80C3D1
CausticumACTIVE INGREDIENTDD5FO1WKFU1
CyanocobalaminACTIVE INGREDIENTP6YC3EG2041
Folic AcidACTIVE INGREDIENT935E97BOY81
Magnesium AscorbateACTIVE INGREDIENT0N1G6785931
Magnesium OxideACTIVE INGREDIENT3A3U0GI71G1
Magnesium Phosphate, Dibasic TrihydrateACTIVE INGREDIENTHF539G9L3Q1
NiacinamideACTIVE INGREDIENT25X51I8RD41
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV1
RiboflavinACTIVE INGREDIENTTLM2976OFR1
Sedum Roseum RootACTIVE INGREDIENT3S5ITS5ULN1
SeleniumACTIVE INGREDIENTH6241UJ22B1
Strychnos Nux-Vomica SeedACTIVE INGREDIENT269XH139191
Thiamine HydrochlorideACTIVE INGREDIENTM572600E5P1
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
BiotinACTIVE MOIETY6SO6U10H041
Calcium PantothenateACTIVE MOIETY568ET80C3D1
CausticumACTIVE MOIETYDD5FO1WKFU1
CyanocobalaminACTIVE MOIETYP6YC3EG2041
Folic AcidACTIVE MOIETY935E97BOY81
Magnesium AscorbateACTIVE MOIETY0N1G6785931
Magnesium CationACTIVE MOIETYT6V3LHY8381
Magnesium OxideACTIVE MOIETY3A3U0GI71G1
NiacinamideACTIVE MOIETY25X51I8RD41
PyridoxineACTIVE MOIETYKV2JZ1BI6Z1
RiboflavinACTIVE MOIETYTLM2976OFR1
Sedum Roseum RootACTIVE MOIETY3S5ITS5ULN1
SeleniumACTIVE MOIETYH6241UJ22B1
Strychnos Nux-Vomica SeedACTIVE MOIETY269XH139191
Thiamine IonACTIVE MOIETY4ABT0J945J1
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS3111
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61U1
CroscarmelloseINACTIVE INGREDIENT029TFK992N1
Dextrose MonohydrateINACTIVE INGREDIENTLX22YL083G1
Egg PhospholipidsINACTIVE INGREDIENT1Z74184RGV1
IcodextrinINACTIVE INGREDIENT2NX48Z0A9G1
Magnesium StearateINACTIVE INGREDIENT70097M6I301
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5P1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H1
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J9901
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULR1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD41
TalcINACTIVE INGREDIENT7SEV7J4R1U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17312-00417312-004-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 391 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Magnesium StearateMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
78 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii candidate
78 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii candidate
28 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii candidate
22 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE / ORAL160 mgExact identifier — unii candidate
44 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / VAGINAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FOR SUSPENSION / ORAL20100 mgExact identifier — unii candidate
28 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
Dextrose MonohydrateDEXTROSE MONOHYDRATELX22YL083GGRANULE, FOR SUSPENSION / ORAL15009 mgExact identifier — unii candidate
12 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, EXTENDED RELEASE / ORAL61 mgExact identifier — unii candidate
28 equally ranked IID candidates
Dextrose MonohydrateDEXTROSE MONOHYDRATELX22YL083GINJECTION, EMULSION / INTRAMUSCULAR938 mgExact identifier — unii candidate
12 equally ranked IID candidates
Dextrose MonohydrateDEXTROSE MONOHYDRATELX22YL083GSPRAY, METERED / NASAL20 mgExact identifier — unii candidate
12 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAMUSCULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR25 mgExact identifier — unii candidate
44 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii candidate
44 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
TalcTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
22 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
IcodextrinICODEXTRIN2NX48Z0A9GTABLET, DELAYED RELEASE / ORAL9.25 mgExact identifier — unii candidate
7 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
TalcTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / OPHTHALMIC1 mgExact identifier — unii candidate
44 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
78 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
TalcTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
Polyvinyl AlcoholPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii candidate
17 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HSUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRASYNOVIAL0.1 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE, FOR SUSPENSION / ORAL15.63 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SOLUTION / ORAL161 mgExact identifier — unii candidate
44 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
Egg PhospholipidsEGG PHOSPHOLIPIDS1Z74184RGVINJECTION / INTRAVENOUS18000 mgExact identifier — unii candidate
5 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dcbfff46-0e86-46be-b01e-b6bf9bf639ba922107dd-bb24-4efe-b034-8296404da7202012-05-31WarningsExact identifier
spl id: dcbfff46-0e86-46be-b01e-b6bf9bf639ba
spl set id: 922107dd-bb24-4efe-b034-8296404da720

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.