NDC 44911-0029 Gastrotone

Gentiana Lutea, Sambucus Nigra, Arsenicum Album, Kali Bichromicum, Lycopodium Clavatum, Phosphorus, Pulsatilla, Bismuthum Carbonicum,

NDC Product Information

Gastrotone with NDC 44911-0029 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Gastrotone is gentiana lutea, sambucus nigra, arsenicum album, kali bichromicum, lycopodium clavatum, phosphorus, pulsatilla, bismuthum carbonicum, . The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energique, 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.

Gastrotone 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.

  • GENTIANA LUTEA ROOT 3 [hp_X]/mL
  • SAMBUCUS NIGRA FLOWERING TOP 3 [hp_C]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • POTASSIUM DICHROMATE 12 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL
  • PULSATILLA VULGARIS 12 [hp_X]/mL
  • BISMUTH SUBCARBONATE 15 [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: Energique, Inc.
Labeler Code: 44911
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: 11-12-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 02-08-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Gastrotone Product Label Images

Gastrotone 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:

Gentiana lutea 3X, Sambucus nigra 3X, Arsenicum album 12X, Kali bichromicum 12X, Lycopodium clavatum 12X, Phosphorus 12X, Pulsatilla 12X, Bismuthum carbonicum 15X.

Indications:

For temporary relief of indigesiton, nausea, retching, vomiting after eating or drinking, monor burning in the stomach. ****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

For temporary relief of indigesiton, nausea, retching, vomiting after eating or drinking, monor burning in the stomach. ****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

If pregnant or breast-feeding, ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Keep Out Of Reach Of Children.

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

Questions:

Dist. by Energique, Inc.201 Apple BlvdWoodbine, IA 51579800-869-8078

Package Label Display

ENERGIQUEsince 1987HOMEOPATHIC REMEDYGASTROTONE1 fl. oz. (30 ml)

* Please review the disclaimer below.