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

Irritable Bowel Syndrome Therapy by

Drug Labeling and Warnings

Irritable Bowel Syndrome Therapy by is a Homeopathic medication manufactured, distributed, or labeled by TRP Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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)