NDC 55714-4426 Constipation

Abies Nig., Aesculus Hipp., Aloe, Alumina, Bryonia, Carbo Veg., Chelidonium Majus, Collinsonia, Graphites, Hydrastis, Kali Carb., Lycopodium, Mag. Mur., Mezereum, Nux Vom., Podoph. Pelt., Rhamnus Purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum Alb., Zinc. Met., Echinacea, Iris Versicolor, Phytolacca, Taraxacum,

NDC Product Code 55714-4426

NDC Code: 55714-4426

Proprietary Name: Constipation 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: Abies Nig., Aesculus Hipp., Aloe, Alumina, Bryonia, Carbo Veg., Chelidonium Majus, Collinsonia, Graphites, Hydrastis, Kali Carb., Lycopodium, Mag. Mur., Mezereum, Nux Vom., Podoph. Pelt., Rhamnus Purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum Alb., Zinc. Met., Echinacea, Iris Versicolor, Phytolacca, Taraxacum, 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

  • 55714 - Newton Laboratories, Inc.
    • 55714-4426 - Constipation

NDC 55714-4426-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC Product Information

Constipation with NDC 55714-4426 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Constipation is abies nig., aesculus hipp., aloe, alumina, bryonia, carbo veg., chelidonium majus, collinsonia, graphites, hydrastis, kali carb., lycopodium, mag. mur., mezereum, nux vom., podoph. pelt., rhamnus purshiana, sanicula, selenium, sepia, silicea, tabacum, veratrum alb., zinc. met., echinacea, iris versicolor, phytolacca, taraxacum,. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Newton Laboratories, 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 Prescription 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.

Constipation 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.

  • PICEA MARIANA RESIN 20 [hp_X]/mL
  • HORSE CHESTNUT 20 [hp_X]/mL
  • ALOE 20 [hp_X]/mL
  • ALUMINUM OXIDE 20 [hp_X]/mL
  • BRYONIA ALBA ROOT 20 [hp_X]/mL
  • ACTIVATED CHARCOAL 20 [hp_X]/mL
  • CHELIDONIUM MAJUS 20 [hp_X]/mL
  • COLLINSONIA CANADENSIS ROOT 20 [hp_X]/mL
  • GRAPHITE 20 [hp_X]/mL
  • GOLDENSEAL 20 [hp_X]/mL
  • POTASSIUM CARBONATE 20 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 20 [hp_X]/mL
  • MAGNESIUM CHLORIDE 20 [hp_X]/mL
  • DAPHNE MEZEREUM BARK 20 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 20 [hp_X]/mL
  • PODOPHYLLUM 20 [hp_X]/mL
  • FRANGULA PURSHIANA BARK 20 [hp_X]/mL
  • SANICULA EUROPAEA WHOLE 20 [hp_X]/mL
  • SELENIUM 20 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 20 [hp_X]/mL
  • SILICON DIOXIDE 20 [hp_X]/mL
  • TOBACCO LEAF 20 [hp_X]/mL
  • VERATRUM ALBUM ROOT 20 [hp_X]/mL
  • ZINC 20 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 8 [hp_X]/mL
  • IRIS VERSICOLOR ROOT 8 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 8 [hp_X]/mL
  • TARAXACUM OFFICINALE 8 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
  • IRIS VERSICOLOR ROOT 3 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 3 [hp_X]/mL
  • TARAXACUM OFFICINALE 3 [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.

  • 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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Plant Proteins - [CS]
  • Seed Storage Proteins - [CS]
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Plant Proteins - [CS]

Product Labeler Information

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

Labeler Name: Newton Laboratories, Inc.
Labeler Code: 55714
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: 06-01-2011 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: 12-31-2019 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.

Constipation Product Label Images

Constipation 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

Product Name & Indications Section

Constipation  Formulated for symptoms associated with acute or chronic constipation due to conditions such as poor diet, pregnancy, inactivity and rectal weakness.

Direction Section

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.

Active Ingredient Section

Abies nig. 20x, Aesculus hipp. 20x, Aloe 20x, Alumina 20x, Bryonia 20x, Carbo veg. 20x, Chelidonium majus 20x, Collinsonia 20x, Graphites 20x, Hydrastis 20x, Kali carb. 20x, Lycopodium 20x, Mag. mur. 20x, Mezereum 20x, Nux vom. 20x, Podoph. pelt. 20x, Rhamnus purshiana 20x, Sanicula 20x, Selenium 20x, Sepia 20x, Silicea 20x, Tabacum 20x, Veratrum alb. 20x, Zinc.met. 20x, Echinacea 8x, Iris versicolor 8x, Phytolacca 8x, Taraxacum 8x, Echinacea 3x, Iris versicolor 3x, Phytolacca 3x, Taraxacum 3x.

Purpose Section

Formulated for symptoms associated with acute or chronic constipation due to conditions such as poor diet, pregnancy, inactivity and rectal weakness.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%

Questions? Section

Www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012Questions?  1.800.448.7256

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.

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