NDC 55714-2389 Bladder - Kidney

Apis Mel., Berber. Vulg., Bryonia, Cantharis, Cinchona, Equisetum Hyemale, Ferrum Phosphoricum, Gelsemium, Juniperus Com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago

NDC Product Code 55714-2389

NDC Code: 55714-2389

Proprietary Name: Bladder - Kidney 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: Apis Mel., Berber. Vulg., Bryonia, Cantharis, Cinchona, Equisetum Hyemale, Ferrum Phosphoricum, Gelsemium, Juniperus Com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago 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.
    • 55714-2389 - Bladder - Kidney

NDC 55714-2389-1

Package Description: 28 g in 1 BOTTLE, GLASS

NDC Product Information

Bladder - Kidney with NDC 55714-2389 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Bladder - Kidney is apis mel., berber. vulg., bryonia, cantharis, cinchona, equisetum hyemale, ferrum phosphoricum, gelsemium, juniperus com., pareira, phosphorus, plantago, pulsatilla, sabal, terebinthina, uva-ursi, echinacea, hydrastis, lappa, solidago. 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 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.

Bladder - Kidney 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.

  • APIS MELLIFERA 15 [hp_X]/g
  • BERBERIS VULGARIS ROOT BARK 15 [hp_X]/g
  • BRYONIA ALBA ROOT 15 [hp_X]/g
  • LYTTA VESICATORIA 15 [hp_X]/g
  • CINCHONA OFFICINALIS BARK 15 [hp_X]/g
  • EQUISETUM HYEMALE 15 [hp_X]/g
  • FERROSOFERRIC PHOSPHATE 15 [hp_X]/g
  • GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/g
  • JUNIPER BERRY 15 [hp_X]/g
  • CHONDRODENDRON TOMENTOSUM ROOT 15 [hp_X]/g
  • PHOSPHORUS 15 [hp_X]/g
  • PLANTAGO MAJOR 15 [hp_X]/g
  • PULSATILLA VULGARIS 15 [hp_X]/g
  • SAW PALMETTO 15 [hp_X]/g
  • TURPENTINE 15 [hp_X]/g
  • ARCTOSTAPHYLOS UVA-URSI LEAF 15 [hp_X]/g
  • ECHINACEA, UNSPECIFIED 6 [hp_X]/g
  • GOLDENSEAL 6 [hp_X]/g
  • ARCTIUM LAPPA ROOT 6 [hp_X]/g
  • SOLIDAGO VIRGAUREA FLOWERING TOP 6 [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.

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: 10-30-2018 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.

Bladder - Kidney Product Label Images

Bladder - Kidney 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

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding Section

If
pregnant or breast-feeding, ask a doctor before use.

Warnings Section

Warning:Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms persist for more than a few day, consult a doctor. If
pregnant or breast-feeding, ask a doctor before use.

Questions Section

Newtonlabs.net ~ Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose free) pellets.

Otc - Purpose Section

Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.

Otc - Active Ingredient Section

Equal parts of Echinacea 6x, Hydrastis 6x, Lappa 6x, Solidago 6x, Apis mel. 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Cinchona 15x, Equisetum hyem. 15x, Ferrum phos. 15x, Gelsemium 15x, Juniperus com. 15x, Pareira 15x, Phos. 15x, Plantago 15x, Pulsatilla 15x, Sabal 15x, Terebinthina 15x, Uva-ursi 15x.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Indications & Usage Section

Bladder - Kidney Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.

* Please review the disclaimer below.

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