NDC 44911-0531 Gut Brain Spectrum

Abrotanum (artemisia Abrotanum), Aethusa Cynapium, Baptisia Tinctoria, Cicuta Virosa, Cuprum Metallicum, Mezereum, Bufo Rana, Lac Materna Humanum, Saccharum Officinale, Serotonin (hydrochloride), Alumina, Calcarea Phosphorica, Candida Albicans, Carcinosin, Helium, Lac Caninum, Mercurius Solubilis, Natrum Muriaticum, Sulphur, Thuja Occidentalis, Formalinum, Morbillinum

NDC Product Code 44911-0531

NDC CODE: 44911-0531

Proprietary Name: Gut Brain Spectrum 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: Abrotanum (artemisia Abrotanum), Aethusa Cynapium, Baptisia Tinctoria, Cicuta Virosa, Cuprum Metallicum, Mezereum, Bufo Rana, Lac Materna Humanum, Saccharum Officinale, Serotonin (hydrochloride), Alumina, Calcarea Phosphorica, Candida Albicans, Carcinosin, Helium, Lac Caninum, Mercurius Solubilis, Natrum Muriaticum, Sulphur, Thuja Occidentalis, Formalinum, Morbillinum 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.

  • Drug uses not available
  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

  • 44911 - Energique, Inc.

NDC 44911-0531-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Gut Brain Spectrum with NDC 44911-0531 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Gut Brain Spectrum is abrotanum (artemisia abrotanum), aethusa cynapium, baptisia tinctoria, cicuta virosa, cuprum metallicum, mezereum, bufo rana, lac materna humanum, saccharum officinale, serotonin (hydrochloride), alumina, calcarea phosphorica, candida albicans, carcinosin, helium, lac caninum, mercurius solubilis, natrum muriaticum, sulphur, thuja occidentalis, formalinum, morbillinum. 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.

Gut Brain Spectrum 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.

  • ARTEMISIA ABROTANUM FLOWERING TOP 6 [hp_X]/mL
  • AETHUSA CYNAPIUM WHOLE 6 [hp_X]/mL
  • BAPTISIA TINCTORIA ROOT 6 [hp_X]/mL
  • CICUTA VIROSA ROOT 12 [hp_X]/mL
  • COPPER 12 [hp_X]/mL
  • DAPHNE MEZEREUM BARK 12 [hp_X]/mL
  • BUFO BUFO CUTANEOUS GLAND 15 [hp_X]/mL
  • HUMAN MILK 30 [hp_X]/mL
  • SUCROSE 30 [hp_X]/mL
  • SEROTONIN HYDROCHLORIDE 30 [hp_X]/mL
  • ALUMINUM OXIDE 12 [hp_C]/mL
  • TRIBASIC CALCIUM PHOSPHATE 12 [hp_C]/mL
  • CANDIDA ALBICANS 12 [hp_C]/mL
  • HUMAN BREAST TUMOR CELL 12 [hp_C]/mL
  • HELIUM 12 [hp_C]/mL
  • CANIS LUPUS FAMILIARIS MILK 12 [hp_C]/mL
  • MERCURIUS SOLUBILIS 12 [hp_C]/mL
  • SODIUM CHLORIDE 12 [hp_C]/mL
  • SULFUR 12 [hp_C]/mL
  • THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_C]/mL
  • FORMALDEHYDE SOLUTION 15 [hp_C]/mL
  • MEASLES VIRUS 15 [hp_C]/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: 03-05-2020 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 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’.

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Gut Brain Spectrum Product Label Images

Gut Brain Spectrum 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:

(in each drop): 4.55% of Abrotanum (Artemisia Abrotanum) 6X, Aethusa Cynapium 6X, Alumina 12C, Baptisia Tinctoria 6X, Bufo Rana 15X, Calcarea Phosphorica 12C, Candida Albicans 12C, Carcinosin 12C, Cicuta Virosa 12X, Cuprum Metallicum 12X, Formalinum 15C, Helium 12C, Lac Caninum 12C, Lac Materna Humanum 30X, Mercurius Solubilis 12C, Mezereum 12X, Morbillinum 15C, Natrum Muriaticum 12C, Saccharum Officinale 30X, Serotonin (Hydrochloride) 30X, Sulphur 12C, Thuja Occidentalis 12C.

Indications:

May temporarily relieve symptoms of dullness with gastro-intestinal discomfort, feeling unconnected to others, and minor symptoms following vaccination.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve symptoms of dullness with gastro-intestinal discomfort, feeling unconnected to others, and minor symptoms following vaccination.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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.

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.

Directions:

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 20% Ethanol

Questions:

Dist. by Energique, Inc.201 Apple Blvd.Woodbine, IA 51579 800.869.8078

Package Display Label:

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYGUT BRAINSPECTRUM1 fl. oz. (30 ml)

* Please review the disclaimer below.