NDC 57955-2708 Allergies Great Lakes U.s.

Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Ambrosia Artemisiaefolia, Chelidonium Majus, Chenopodium Vulvaria, Cichorium Intybus, Cortisone Aceticum, Euphrasia Officinalis, Galphimia Glauca, Hedera Helix, Histaminum Hydrochloricum, Juglans Cinerea, Kali Muriaticum, Mucosa Nasalis Suis, Natrum Muriaticum, Pulsatilla Nuttalliana, Rna, Sabadilla, Teucrium Scorodonia

NDC Product Code 57955-2708

NDC Code: 57955-2708

Proprietary Name: Allergies Great Lakes U.s. 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: Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Ambrosia Artemisiaefolia, Chelidonium Majus, Chenopodium Vulvaria, Cichorium Intybus, Cortisone Aceticum, Euphrasia Officinalis, Galphimia Glauca, Hedera Helix, Histaminum Hydrochloricum, Juglans Cinerea, Kali Muriaticum, Mucosa Nasalis Suis, Natrum Muriaticum, Pulsatilla Nuttalliana, Rna, Sabadilla, Teucrium Scorodonia 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

  • 57955 - King Bio Inc.
    • 57955-2708 - Allergies Great Lakes U.s.

NDC 57955-2708-2

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Allergies Great Lakes U.s. with NDC 57955-2708 is a a human over the counter drug product labeled by King Bio Inc.. The generic name of Allergies Great Lakes U.s. is adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, chelidonium majus, chenopodium vulvaria, cichorium intybus, cortisone aceticum, euphrasia officinalis, galphimia glauca, hedera helix, histaminum hydrochloricum, juglans cinerea, kali muriaticum, mucosa nasalis suis, natrum muriaticum, pulsatilla nuttalliana, rna, sabadilla, teucrium scorodonia. The product's dosage form is liquid and is administered via oral form.

Labeler Name: King Bio 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.

Allergies Great Lakes U.s. 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.

  • ADENOSINE CYCLIC PHOSPHATE 12 [hp_X]/59mL
  • EPINEPHRINE 12 [hp_X]/59mL
  • CORTICOTROPIN 12 [hp_X]/59mL
  • ONION 12 [hp_X]/59mL
  • AMBROSIA ARTEMISIIFOLIA 12 [hp_X]/59mL
  • CHELIDONIUM MAJUS 12 [hp_X]/59mL
  • CHENOPODIUM VULVARIA 12 [hp_X]/59mL
  • CHICORY ROOT 12 [hp_X]/59mL
  • CORTISONE ACETATE 12 [hp_X]/59mL
  • EUPHRASIA STRICTA 12 [hp_X]/59mL
  • GALPHIMIA GLAUCA FLOWERING TOP 12 [hp_X]/59mL
  • HEDERA HELIX FLOWERING TWIG 12 [hp_X]/59mL
  • HISTAMINE DIHYDROCHLORIDE 12 [hp_X]/59mL
  • JUGLANS CINEREA BRANCH BARK/ROOT BARK 12 [hp_X]/59mL
  • POTASSIUM CHLORIDE 12 [hp_X]/59mL
  • SUS SCROFA NASAL MUCOSA 12 [hp_X]/59mL
  • SODIUM CHLORIDE 12 [hp_X]/59mL
  • ANEMONE PATENS 12 [hp_X]/59mL
  • SACCHAROMYCES CEREVISIAE RNA 12 [hp_X]/59mL
  • SCHOENOCAULON OFFICINALE SEED 12 [hp_X]/59mL
  • TEUCRIUM SCORODONIA FLOWERING TOP 12 [hp_X]/59mL

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)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • 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: King Bio Inc.
Labeler Code: 57955
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: 06-20-2014 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: 12-31-2018 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: E 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.

Allergies Great Lakes U.s. Product Label Images

Allergies Great Lakes U.s. 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 - Active Ingredient

Drug Facts​__________________________________________________________________________________________________________HPUS active ingredients: ​Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Pulsatilla nuttalliana, RNA, Sabadilla, Teucrium scorodonia. Equal volumes of each ingredient in 12X, 24X, 30X, LM1, LM2, LM3, LM5 potencies.

Indications & Usage

Uses ​for temporary relief of symptoms: red, itchy, watery eyes, sore throat, cough, hoarseness, fatigue, runny nose, sneezing, congestion, and headache.

Inactive Ingredient

Inactive Ingredients: Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Warnings

  • WarningsStop use and ask your doctor if symptoms persist or worsen.If pregnant or breast-feeding, take only on advice of a healthcare professional.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

  • DirectionsInitially, depress pump until primed.Spray one dose directly into mouth.Adults 12 and up: 3 sprays 3 times per day.Children 2-12: 2 sprays 3 times per day.Children 2 mo-2 yr: 1 spray 3 times per day.

Other Safety Information

Tamper resistant for your protection. Use only if seal is intact. This product has not been independently tested.

Otc - Purpose

  • Uses for temporary relief of symptoms:red, itchy, watery eyessore throatcoughhoarsenessfatiguerunny nosesneezingcongestionheadache

* Please review the disclaimer below.

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