Irritable Bowel Syndrome Therapy Tablet, Orally Disintegrating
FDA Label NDC 17312-019

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trp Company for the product Irritable Bowel Syndrome Therapy (NDC 17312-019). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Directions

→ Other Information

→ Inactive Ingredients

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - 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.

Otc - 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

Indications & Usage

Uses:*

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

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.

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

Otc - Stop Use

Stop use and ask a doctor if:

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

Otc - Pregnancy Or Breast Feeding

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

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.

Otc - Questions

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

Package Label.Principal Display Panel

* Please review the disclaimer below.

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