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

  • 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 April 13, 2020

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

  • 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

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

  • Keep out of reach of children

    Keep out of reach of children

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

  • WARNINGS

    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.

  • 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

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

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

  • QUESTIONS

    www.thereliefproducts.com, 1-888-969-6855

  • 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

    Stop use and ask a doctor if:

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

    LabelCarton

  • 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 disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-019
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA3 [hp_X]
    BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE6 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL6 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE6 [hp_X]
    SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE6 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeDIAMONDSize13mm
    FlavorImprint Code TRP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-019-141 in 1 PACKAGE05/05/2015
    170 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2011
    Labeler - TRP Company (105185719)
    Registrant - TRP Company (105185719)