Label: IRRITABLE 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
- NDC Code(s): 17312-019-14
- Packager: TRP Company
- 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 September 18, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
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. -
PURPOSE
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
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children
- WARNINGS
-
Directions
- 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
- 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
- Do not use if tamper evident seal is torn, broken or missing.
- QUESTIONS
-
Indications and usage
Uses:*
According to homeopathic indications these ingredients temporarily relieve symptoms such as: • loose stools • bloating • dry, hard stools • cramping • irritability • flatulence • irregularity • stomach discomfort after a diagnosis by a physician.
*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
- Stop use
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IRRITABLE 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 disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17312-019 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA 3 [hp_X] BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE 6 [hp_X] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 6 [hp_X] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 6 [hp_X] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_X] VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT 6 [hp_X] Inactive Ingredients Ingredient Name Strength MANNITOL (UNII: 3OWL53L36A) SORBITOL (UNII: 506T60A25R) CROSPOVIDONE (UNII: 68401960MK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) COPOVIDONE (UNII: D9C330MD8B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape DIAMOND Size 13mm Flavor Imprint Code TRP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17312-019-14 1 in 1 PACKAGE 05/05/2015 1 70 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2011 Labeler - TRP Company (105185719) Registrant - TRP Company (105185719)
