FDA.reportPublic FDA data

Temporary Fibromyalgia Pain and Discomfort Relief

Manufacturer
TRP Company
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:15:19

Label at a glance#

ProductTemporary Fibromyalgia Pain and Discomfort Relief
Active ingredientATROPA BELLADONNA, BRYONIA ALBA ROOT, CAUSTICUM, PHOSPHORUS, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF
Label structure12 sections

Indications and uses

According to homeopathic indications these ingredients provide temporary relief from symptoms of Fibromyalgia such as: • Muscle soreness • Fatigue • Nerve / Soft tissue tenderness • Multiple tender points after diagnosis by a physician. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Dosage and administration

Suitable for adults and children 12 years and above. Dissolve entire tablet under tongue. Do not chew or swallow whole. Take 1 tablet 3 times a day or as directed by a physician. Use up to 6 times a day as needed. Take at least 10 minutes before or at least 10 minutes after eating or drinking. Children under the age of 12: consult a physician before use.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Belladonna HPUS 6c, 12c, 18c
Bryonia HPUS 6c, 12c, 18c
Causticum HPUS 6c, 12c, 18c
Magnesia Phosphorica HPUS 6c,12c,18c
Nux Vomica HPUS 6c,12c,18c
Pulsatilla HPUS 6c,12c,18c
Rhus Tox HPUS 6c,12c,18c

HPUS indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Belladonna HPUS - Chronic discomfort, Fatigue
Bryonia HPUS - Difficulty moving, Stiff joints, Acute soreness
Causticum HPUS - Muscle and nerve soreness
Magnesia Phosphorica HPUS - Cramping, Fatigue
Nux Vomica HPUS - Sleeplessness, Irritable bowels
Pulsatilla HPUS - Migrating soreness
Rhus Tox HPUS - Soft tissue discomfort

Uses

INDICATIONS & USAGE SECTION

According to homeopathic indications these ingredients provide temporary relief from symptoms of Fibromyalgia such as: • Muscle soreness • Fatigue • Nerve / Soft tissue tenderness • Multiple tender points after diagnosis by a physician.

* These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Suitable for adults and children 12 years and above.
  • Dissolve entire tablet under tongue.
  • Do not chew or swallow whole.
  • Take 1 tablet 3 times a day or as directed by a physician.
  • Use up to 6 times a day as needed.
  • Take at least 10 minutes before or at least 10 minutes after eating or drinking.
  • Children under the age of 12: consult a physician before use.

Other information

SPL UNCLASSIFIED SECTION

There are no known contraindications.

  • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side cool dark location. Temporary Fibromyalgia Pain and Discomfort Relief® Fast Dissolving TabletsTM are homeopathic dilutions, for details see www.thereliefproducts.com.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

OTC - QUESTIONS SECTION

For more information and to order related products call toll free: 888-969-6855 or trpcompany.com

Do not use

OTC - DO NOT USE SECTION

Do not use if tamper evident seal is torn, broken or missing.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if:

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

Warning

WARNINGS SECTION

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN.

  • This product is intended to complement, not replace, standard medical treatment.
  • Initial worsening of symptoms may occur.
  • A physician should always be consulted regarding Fibromyalgia to rule out serious causes.
  • In case of overdose, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonLabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17312-016TEMPORARY FIBROMYALGIA PAIN AND DISCOMFORT RELIEF (ATROPA BELLADONNA - BRYONIA ALBA ROOT - CAUSTICUM - PHOSPHORUS - STRYCHNOS NUX-VOMICA SEED - PULSATILLA VULGARIS - TOXICODENDRON PUBESCENS LEAF -) TABLET, ORALLY DISINTEGRATING [TRP COMPANY]6Legacy NDC20240110_3aa51feb-56fe-4a89-aef5-d02481432c23.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H3
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B3
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU3
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W3
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV3
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139193
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A3
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H3
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B3
CAUSTICUMACTIVE MOIETYDD5FO1WKFU3
PHOSPHORUSACTIVE MOIETY27YLU75U4W3
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV3
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139193
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
COPOVIDONEINACTIVE INGREDIENTD9C330MD8B3
CROSPOVIDONEINACTIVE INGREDIENT68401960MK3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303
MANNITOLINACTIVE INGREDIENT3OWL53L36A3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
SORBITOLINACTIVE INGREDIENT506T60A25R3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17312-01617312-016-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
MANNITOL3OWL53L36AIACT
SORBITOL506T60A25RIACT
CROSPOVIDONE68401960MKIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
COPOVIDONED9C330MD8BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CAUSTICUMDD5FO1WKFUACTIB
PHOSPHORUS27YLU75U4WACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB

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 5 · 277 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii candidate
36 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BCAPSULE / ORAL1346 mgExact identifier — unii candidate
16 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS980.4 mgExact identifier — unii candidate
65 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BTABLET, ORALLY DISINTEGRATING / ORAL35 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / TOPICAL4 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR113 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, EXTENDED RELEASE / ORAL160 mgExact identifier — unii candidate
65 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SUSPENSION / ORAL2553 mgExact identifier — unii candidate
49 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BCAPSULE, COATED PELLETS / ORAL88 mgExact identifier — unii candidate
16 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBCUTANEOUS99 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BTABLET, CHEWABLE / ORAL5 mgExact identifier — unii candidate
16 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / ORAL7093 mgExact identifier — unii candidate
65 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASPRAY / NASAL41.5 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAMUSCULAR71 mgExact identifier — unii candidate
65 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / BUCCAL296.7 mgExact identifier — unii candidate
36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
28 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / INTRAMUSCULAR6.75 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BTABLET / SUBLINGUAL54 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BTABLET, DELAYED RELEASE / ORAL168 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, DELAYED RELEASE / ORAL2043 mgExact identifier — unii candidate
65 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAVENOUS15200 mgExact identifier — unii candidate
65 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / SUBLINGUAL10.25 mgExact identifier — unii candidate
65 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / RECTAL46.18 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAVENOUS203.5 mgExact identifier — unii candidate
36 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
43d41246-2aba-f376-e063-6394a90ad7063aa51feb-56fe-4a89-aef5-d02481432c232025-11-17WarningsExact identifier
spl set id: 3aa51feb-56fe-4a89-aef5-d02481432c23

Reported adverse events (FAERS/openFDA)#

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