FDA.reportPublic FDA data

Irritable Bowel Syndrome Therapy™ Homeopathic Fast Dissolving Tablets

Manufacturer
TRP Company
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:40:58

Label at a glance#

ProductIrritable Bowel Syndrome Therapy
Active ingredientASAFETIDA, BISMUTH SUBNITRATE, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, LYCOPODIUM CLAVATUM SPORE, SODIUM CARBONATE, STRYCHNOS NUX-VOMICA SEED, VERATRUM ALBUM ROOT
Label structure11 sections

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. Homeopathic remedies may not be effective for everyone.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Asafoetida HPUS 3x 6x 12x 18x

Bismuthum subnitricum HPUS 6x 12x 18x

Bryonia HPUS 6x 12x 18x

Carbo vegetabilis HPUS 6x 12x 18x

Lycopodium Clavatum HPUS 6x 12x 18x

Natrum carbonicum HPUS 6x 12x 18x

Nux vomica HPUS 6x 12x 18x

Veratrum album HPUS 6x 12x 18x

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

OTC - PURPOSE SECTION

Asafoetida HPUS - Bloating, Cramping

Bismuthum subnitricum HPUS - Irritation

Bryonia HPUS - Dry, hard stools

Carbo vegetabilis HPUS - Indigestion, Belching

Lycopodium Clavatum HPUS - Loose stools, Flatulence

Natrum carbonicum HPUS - Stomach discomfort

Nux vomica HPUS - Irritability

Veratrum album HPUS - Irregularity

INDICATIONS & USAGE SECTION

Uses:*

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

WARNINGS SECTION

Warnings:

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF 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 to rule out serious causes.

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • You experience worsening symptoms.
  • If symptoms last longer than 7 days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

WARNINGS SECTION

  • In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Homeopathic remedies may not be effective for everyone.

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 effects.
  • Store in a cool dark location.
  • Irritable Bowel Syndrome Therapy™ Homeopathic Fast Dissolving Tablet are homeopathic dilutions: see www.thereliefproducts.com for details.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


BoxBox

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17312-034IRRITABLE BOWEL SYNDROME THERAPY (ASAFETIDA - BISMUTH SUBNITRATE - BRYONIA ALBA ROOT - ACTIVATED CHARCOAL - LYCOPODIUM CLAVATUM SPORE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT -) TABLET, ORALLY DISINTEGRATING [TRP COMPANY]3Legacy NDC20230111_317ce456-aa6c-0b51-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17312-03417312-034-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
MANNITOL3OWL53L36AIACT
SORBITOL506T60A25RIACT
CROSPOVIDONE68401960MKIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
COPOVIDONED9C330MD8BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
ASAFETIDAW9FZA51AS1ACTIB
BISMUTH SUBNITRATEH19J064BA5ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM CARBONATE45P3261C7TACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB

Source Document#

Source XML

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
43d4085c-5cf6-903e-e063-6294a90a1bb4317ce456-aa6c-0b51-e054-00144ff8d46c2025-11-17WarningsExact identifier
spl set id: 317ce456-aa6c-0b51-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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