NDC 17312-019 Irritable Bowel Syndrome Therapy

Asafetida - Bismuth Subnitrate - Bryonia Alba Root - Activated Charcoal - Lycopodium Clavatum Spore - Sodium Carbonate - Strychnos Nux-vomica Seed - Veratrum Album Root -

NDC Product Code 17312-019

NDC CODE: 17312-019

Proprietary Name: Irritable Bowel Syndrome Therapy What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Asafetida - Bismuth Subnitrate - Bryonia Alba Root - Activated Charcoal - Lycopodium Clavatum Spore - Sodium Carbonate - Strychnos Nux-vomica Seed - Veratrum Album Root - What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: DIAMOND (C48338)
Size(s):
13 MM
Imprint(s):
TRP
Score: 1

NDC Code Structure

  • 17312 - Trp Company

NDC 17312-019-14

Package Description: 1 BOTTLE in 1 PACKAGE > 70 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

NDC Product Information

Irritable Bowel Syndrome Therapy with NDC 17312-019 is a a human over the counter drug product labeled by Trp Company. The generic name of Irritable Bowel Syndrome Therapy is asafetida - bismuth subnitrate - bryonia alba root - activated charcoal - lycopodium clavatum spore - sodium carbonate - strychnos nux-vomica seed - veratrum album root -. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

Labeler Name: Trp Company

Dosage Form: Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Irritable Bowel Syndrome Therapy Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ASAFETIDA 3 [hp_X]/1
  • BISMUTH SUBNITRATE 6 [hp_X]/1
  • BRYONIA ALBA ROOT 6 [hp_X]/1
  • ACTIVATED CHARCOAL 6 [hp_X]/1
  • LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/1
  • SODIUM CARBONATE 6 [hp_X]/1
  • STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/1
  • VERATRUM ALBUM ROOT 6 [hp_X]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Trp Company
Labeler Code: 17312
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Irritable Bowel Syndrome Therapy Product Label Images

Irritable Bowel Syndrome Therapy Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

* Please review the disclaimer below.