NDC 55714-4543 Edema

Elaps Corallinus , Apis Mel., Arsenicum Alb. , Cantharis, Cinchona , Colchicum , Convallaria , Crotalus Horridus , Digitalis , Juniperus Com , Lachesis , Merc. Viv. , Naja , Nat. Carb. , Nat. Sulphuricum , Rhus Toxicodendron , Sambucus Nig. , Strophanthus Hispidus , Thuja Occ. , Vipera Berus , Echinacea , Lappa , Solidago , Taraxacum , Urtica Ur.

NDC Product Code 55714-4543

NDC Code: 55714-4543

Proprietary Name: Edema 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: Elaps Corallinus , Apis Mel., Arsenicum Alb. , Cantharis, Cinchona , Colchicum , Convallaria , Crotalus Horridus , Digitalis , Juniperus Com , Lachesis , Merc. Viv. , Naja , Nat. Carb. , Nat. Sulphuricum , Rhus Toxicodendron , Sambucus Nig. , Strophanthus Hispidus , Thuja Occ. , Vipera Berus , Echinacea , Lappa , Solidago , Taraxacum , Urtica Ur. 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.
    • 55714-4543 - Edema

NDC 55714-4543-1

Package Description: 28.35 g in 1 BOTTLE, GLASS

NDC 55714-4543-2

Package Description: 56.7 g in 1 BOTTLE, GLASS

NDC Product Information

Edema with NDC 55714-4543 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Edema is elaps corallinus , apis mel., arsenicum alb. , cantharis, cinchona , colchicum , convallaria , crotalus horridus , digitalis , juniperus com , lachesis , merc. viv. , naja , nat. carb. , nat. sulphuricum , rhus toxicodendron , sambucus nig. , strophanthus hispidus , thuja occ. , vipera berus , echinacea , lappa , solidago , taraxacum , urtica ur.. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Newton Laboratories, Inc.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Edema 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.

  • MICRURUS CORALLINUS VENOM 35 [hp_X]/g
  • APIS MELLIFERA 15 [hp_X]/g
  • ARSENIC TRIOXIDE 15 [hp_X]/g
  • LYTTA VESICATORIA 15 [hp_X]/g
  • CINCHONA OFFICINALIS BARK 15 [hp_X]/g
  • COLCHICUM AUTUMNALE BULB 15 [hp_X]/g
  • CONVALLARIA MAJALIS 15 [hp_X]/g
  • CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X]/g
  • DIGITALIS 15 [hp_X]/g
  • JUNIPERUS COMMUNIS FRUIT 15 [hp_X]/g
  • LACHESIS MUTA VENOM 15 [hp_X]/g
  • MERCURY 15 [hp_X]/g
  • NAJA NAJA VENOM 15 [hp_X]/g
  • SODIUM CARBONATE 15 [hp_X]/g
  • SODIUM SULFATE 15 [hp_X]/g
  • TOXICODENDRON PUBESCENS LEAF 15 [hp_X]/g
  • SAMBUCUS NIGRA FLOWERING TOP 15 [hp_X]/g
  • STROPHANTHUS HISPIDUS SEED 15 [hp_X]/g
  • THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]/g
  • VIPERA BERUS VENOM 15 [hp_X]/g
  • ECHINACEA, UNSPECIFIED 8 [hp_X]/g
  • ARCTIUM LAPPA ROOT 8 [hp_X]/g
  • SOLIDAGO VIRGAUREA FLOWERING TOP 8 [hp_X]/g
  • TARAXACUM OFFICINALE 8 [hp_X]/g
  • URTICA URENS 8 [hp_X]/g

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.

  • SUCROSE (UNII: C151H8M554)

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.

  • Standardized Insect Venom 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]
  • Bee Venoms - [CS]
  • Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Dietary Proteins - [CS]
  • Plant Proteins - [CS]
  • Food Additives - [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.

Edema Product Label Images

Edema 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

Indications & Usage Section

Edema  Formulated for symptoms associated with generalized or peripheral edema due to injury or various health conditions.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.

Active Ingredient Section

Elaps corallinus 35x, Apis mel.15x, Arsenicum alb. 15x, Cantharis 15x, Cinchona 15x, Colchicum 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Juniperus com 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Rhus toxicodendron 15x, Sambucus nig. 15x, Strophanthus hispidus 15x, Thuja occ. 15x, Vipera berus 15x, Echinacea 8x, Lappa 8x, Solidago 8x, Taraxacum 8x, Urtica ur. 8x, Echinacea 3x, Lappa 3x, Solidago 3x, Taraxacum 3x, Urtica ur. 3x.

Purpose Section

Formulated for symptoms associated with generalized or peripheral edema due to injury or various health conditions.

Inactive Ingredient Section

Inactive Ingredients:  Gluten-free, non-GMO, beet-derived sucrose pellets.

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.

Pregnancy Or Breast Feeding Section

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

Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.

Previous Code
55714-4542
Next Code
55714-4544