NDC 43742-1304 Gi Distress

Echinacea (angustifolia), Natrum Phosphoricum, Colchicum Autumnale, Arsenicum Album, Colocynthis, Croton Tiglium, Gambogia, Aceticum Acidum, Antimonium Crudum, Bismuthum Subnitricum, Cinchona Officinalis, Ferrum Metallicum, Iris Versicolor, Lac Defloratum, Mercurius Vivus, Nux Vomica, Ricinus Communis, Veratrum Album, Colibacillinum Cum Natrum Muriaticum, Proteus (mirabilis)

NDC Product Code 43742-1304

NDC CODE: 43742-1304

Proprietary Name: Gi Distress 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: Echinacea (angustifolia), Natrum Phosphoricum, Colchicum Autumnale, Arsenicum Album, Colocynthis, Croton Tiglium, Gambogia, Aceticum Acidum, Antimonium Crudum, Bismuthum Subnitricum, Cinchona Officinalis, Ferrum Metallicum, Iris Versicolor, Lac Defloratum, Mercurius Vivus, Nux Vomica, Ricinus Communis, Veratrum Album, Colibacillinum Cum Natrum Muriaticum, Proteus (mirabilis) 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).
  • Acetic acid is used to treat an outer ear infection (external otitis). It works by stopping the growth of bacteria and fungus. Treating the infection reduces pain and swelling in the ear. Wetness in the ear canal can help bacteria and fungus to grow. This medication may also contain drying ingredients such as glycerin or alcohol. Drying of the ear canal helps to cure the infection.
  • This medication is an iron supplement used to treat or prevent low blood levels of iron (e.g., for anemia or during pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.

NDC Code Structure

  • 43742 - Deseret Biologicals, Inc.

NDC 43742-1304-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Gi Distress with NDC 43742-1304 is a a human over the counter drug product labeled by Deseret Biologicals, Inc.. The generic name of Gi Distress is echinacea (angustifolia), natrum phosphoricum, colchicum autumnale, arsenicum album, colocynthis, croton tiglium, gambogia, aceticum acidum, antimonium crudum, bismuthum subnitricum, cinchona officinalis, ferrum metallicum, iris versicolor, lac defloratum, mercurius vivus, nux vomica, ricinus communis, veratrum album, colibacillinum cum natrum muriaticum, proteus (mirabilis). The product's dosage form is liquid and is administered via oral form.

Labeler Name: Deseret Biologicals, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Gi Distress 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.

  • ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL
  • SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X]/mL
  • COLCHICUM AUTUMNALE BULB 8 [hp_X]/mL
  • ARSENIC TRIOXIDE 8 [hp_X]/mL
  • CITRULLUS COLOCYNTHIS FRUIT PULP 9 [hp_X]/mL
  • CROTON TIGLIUM SEED 9 [hp_X]/mL
  • GAMBOGE 9 [hp_X]/mL
  • ACETIC ACID 12 [hp_X]/mL
  • ANTIMONY TRISULFIDE 12 [hp_X]/mL
  • BISMUTH SUBNITRATE 12 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 12 [hp_X]/mL
  • IRON 12 [hp_X]/mL
  • IRIS VERSICOLOR ROOT 12 [hp_X]/mL
  • SKIM MILK 12 [hp_X]/mL
  • MERCURY 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL
  • RICINUS COMMUNIS SEED 12 [hp_X]/mL
  • VERATRUM ALBUM ROOT 12 [hp_X]/mL
  • ESCHERICHIA COLI 16 [hp_X]/mL
  • PROTEUS MIRABILIS 16 [hp_X]/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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.
  • 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: Deseret Biologicals, Inc.
Labeler Code: 43742
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: 09-26-2018 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Gi Distress Product Label Images

Gi Distress 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

Active Ingredients:

Echinacea (Angustifolia) 3X, Natrum Phosphoricum 6X, Colchicum Autumnale 8X, Arsenicum Album 8X, 12X 30X, Colocynthis 9X, Croton Tiglium 9X, Gambogia 9X, Aceticum Acidum 12X, Antimonium Crudum 12X, Bismuthum Subnitricum 12X, Cinchona Officinalis 12X, Ferrum Metallicum 12X, Iris Versicolor 12X, Lac Defloratum 12X, Mercurius Vivus 12X, Nux Vomica 12X, Ricinus Communis 12X, Veratrum Album 12X, Colibacillinum Cum Natrum Muriaticum 16X, Proteus (Mirabilis) 16X.

Homeopathic Indications:

For the temporary relief of symptoms related to occasional watery diarrhea, irritation of stomach, indigestion, abdominal bloating, stomach cramps, and loss of appetite.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

For the temporary relief of symptoms related to occasional watery diarrhea, irritation of stomach, indigestion, abdominal bloating, stomach cramps, and loss of appetite.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Warnings:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.If pregnant or breast-feeding, ask a health professional before use.Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

Directions:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Questions:

Dist. By: Deseret Biologicals, Inc.469 W. Parkland DriveSandy, UT 84070 www.desbio.com

Package Label Display:

DESBIONDC 43742-1304-1HOMEOPATHICGI DISTRESS1 FL OZ (30 ml)

* Please review the disclaimer below.