NDC 55714-4794 Throat Care

Echinacea, Aconitum Nap., Apis Mel., Arum Drac., Belladonna, Bryonia, Cajuputum, Ferrum Phos., Glycyrrhiza, Kali Bic., Lachesis, Menta Pip., Merc. Viv., Naja, Nat. Carb., Nat Sulphuricum, Nitricum Ac., Nux Vom., Phos., Phytolacca, Pulsatilla, Spongia, Stannum Met., Sticta, Thuja Occ., Ulmus Fulv., Verbascum

NDC Product Code 55714-4794

NDC CODE: 55714-4794

Proprietary Name: Throat Care 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: Echinacea, Aconitum Nap., Apis Mel., Arum Drac., Belladonna, Bryonia, Cajuputum, Ferrum Phos., Glycyrrhiza, Kali Bic., Lachesis, Menta Pip., Merc. Viv., Naja, Nat. Carb., Nat Sulphuricum, Nitricum Ac., Nux Vom., Phos., Phytolacca, Pulsatilla, Spongia, Stannum Met., Sticta, Thuja Occ., Ulmus Fulv., Verbascum 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.

NDC 55714-4794-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Throat Care with NDC 55714-4794 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Throat Care is echinacea, aconitum nap., apis mel., arum drac., belladonna, bryonia, cajuputum, ferrum phos., glycyrrhiza, kali bic., lachesis, menta pip., merc. viv., naja, nat. carb., nat sulphuricum, nitricum ac., nux vom., phos., phytolacca, pulsatilla, spongia, stannum met., sticta, thuja occ., ulmus fulv., verbascum. 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 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.

Throat Care 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.

  • PHYTOLACCA AMERICANA ROOT 15 [hp_X]/mL
  • ANEMONE PULSATILLA 15 [hp_X]/mL
  • BRYONIA ALBA ROOT 15 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 6 [hp_X]/mL
  • ACONITUM NAPELLUS 15 [hp_X]/mL
  • APIS MELLIFERA 15 [hp_X]/mL
  • ULMUS RUBRA BARK 15 [hp_X]/mL
  • CAJUPUT OIL 15 [hp_X]/mL
  • MERCURY 15 [hp_X]/mL
  • NAJA NAJA VENOM 15 [hp_X]/mL
  • POTASSIUM DICHROMATE 15 [hp_X]/mL
  • LACHESIS MUTA VENOM 15 [hp_X]/mL
  • MENTHA PIPERITA 15 [hp_X]/mL
  • SODIUM CARBONATE 15 [hp_X]/mL
  • SODIUM SULFATE 15 [hp_X]/mL
  • NITRIC ACID 15 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA WHOLE 15 [hp_X]/mL
  • PHOSPHORUS 15 [hp_X]/mL
  • SPONGIA OFFICINALIS SKELETON, ROASTED 15 [hp_X]/mL
  • LOBARIA PULMONARIA 15 [hp_X]/mL
  • THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]/mL
  • FERROSOFERRIC PHOSPHATE 15 [hp_X]/mL
  • GLYCYRRHIZA GLABRA 15 [hp_X]/mL
  • TIN 15 [hp_X]/mL
  • VERBASCUM THAPSUS 15 [hp_X]/mL
  • ARISAEMA DRACONTIUM ROOT 15 [hp_X]/mL
  • ATROPA BELLADONNA 15 [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.

  • 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.

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 MEDICAL GAS - 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: 09-02-2019 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: 12-31-2021 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’.

* Please review the disclaimer below.

Throat Care Product Label Images

Throat Care 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 And Usage Section

Formulated for associated symptoms such as dryness, irritation, inflammation, pain and hoarseness.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

Otc - Active Ingredient Section

Equal parts of Echinacea 6x, Aconitum nap. 15x, Apis mel. 15x, Arum drac. 15x, Belladonna 15x, Bryonia 15x, Cajuputum 15x, Ferrum phos. 15x, Glycyrrhiza 15x, Kali bic. 15x, Lachesis 15x, Menta pip. 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Nitricum ac. 15x, Nux vom. 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Spongia 15x, Stannum met. 15x, Sticta 15x, Thuja occ. 15x, Ulmus fulv. 15x, Verbascum 15x.

Otc - Purpose Section

Formulated for associated symptoms such as dryness, irrtiation, inflammation, pain and hoarseness.

Inactive Ingredient Section

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%

Questions Section

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

Warnings Section

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

Otc - Pregnancy Or Breast Feeding Section

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

Otc - Keep Out Of Reach Of Children Section

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

* Please review the disclaimer below.