NDC 44911-0512 Genstat

Aesculus Hippocastanum, Equisetum Hyemale, Fumaria Officinalis, Hydrocotyle Asiatica, Oleum Olea Europaea, Passiflora Incarnata, Ribes Nigrum, Solidago Virgaurea, Ononis Spinosa

NDC Product Code 44911-0512

NDC Code: 44911-0512

Proprietary Name: Genstat 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: Aesculus Hippocastanum, Equisetum Hyemale, Fumaria Officinalis, Hydrocotyle Asiatica, Oleum Olea Europaea, Passiflora Incarnata, Ribes Nigrum, Solidago Virgaurea, Ononis Spinosa 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.

NDC Code Structure

NDC 44911-0512-1

Package Description: 120 mL in 1 BOTTLE, DROPPER

NDC Product Information

Genstat with NDC 44911-0512 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Genstat is aesculus hippocastanum, equisetum hyemale, fumaria officinalis, hydrocotyle asiatica, oleum olea europaea, passiflora incarnata, ribes nigrum, solidago virgaurea, ononis spinosa. 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.

Genstat 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.

  • HORSE CHESTNUT 6 [hp_X]/mL
  • EQUISETUM HYEMALE 6 [hp_X]/mL
  • FUMARIA OFFICINALIS FLOWERING TOP 6 [hp_X]/mL
  • CENTELLA ASIATICA 6 [hp_X]/mL
  • OLIVE OIL 6 [hp_X]/mL
  • PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_X]/mL
  • RIBES NIGRUM LEAF 6 [hp_X]/mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 6 [hp_X]/mL
  • ONONIS SPINOSA WHOLE 14 [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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

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: 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: 09-11-2019 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.

Genstat Product Label Images

Genstat 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): 11.11% of Aesculus Hippocastanum 6X, Equisetum Hyemale 6X, Fumaria Officinalis 6X, Hydrocotyle Asiatica 6X, Oleum Olea Europaea 6X, Ononis Spinosa 14C, Passiflora Incarnata 6X, Ribes Nigrum 6X, Solidago Virgaurea 6X.

Indications:

May temporarily relieve symptoms associated with general toxicity, such as the sudden desire to urinate, weakness and fatigue, increased mucus leading to cough or hoarseness, abdominal bloating, constipation alternating with diarrhea, muscle stiffness, soreness and pain.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve symptoms associated with general toxicity, such as the sudden desire to urinate, weakness and fatigue, increased mucus leading to cough or hoarseness, abdominal bloating, constipation alternating with diarrhea, muscle stiffness, soreness and pain.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

If pregnant or breastfeeding, 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:

4 to 5 droppersful in a glass of juice before breakfast.

Inactive Ingredients:

Citric acid, Demineralized water, Magnesium chloride, Potassium sorbate

Questions:

Dist. by Energique, Inc., 201 Apple Blvd.Woodbine, IA 51579   800.868.8078

Package Label Display:

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYGENSTAT4 fl. oz. (120 ml)

* Please review the disclaimer below.