NDC 57955-0752 Regional 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, Rna, Sabadilla, Teucrium Scorodonia

NDC Product Code 57955-0752

NDC Code: 57955-0752

Proprietary Name: Regional 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, 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.
    • 57955-0752 - Regional Allergies Great Lakes U.s.

NDC 57955-0752-2

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Regional Allergies Great Lakes U.s. with NDC 57955-0752 is a a human over the counter drug product labeled by King Bio Inc.. The generic name of Regional 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, 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.

Regional 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 30 [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)
  • CARYA OVATA BARK (UNII: X765CF609L)
  • CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
  • LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
  • POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)
  • REBAUDIOSIDE A (UNII: B3FUD0528F)

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: 04-11-2018 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.

Regional Allergies Great Lakes U.s. Product Label Images

Regional 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(30X), 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, RNA, Sabadilla, Teucrium scorodonia.

Indications & Usage

Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, MI, MN, MO, OH, WI: •itchy, watery eyes •runny nose •sneezing •sore throat •sinus congestion •cough •stuffy nose •fatigue •itchy, irritated skin •hoarseness •headache.† as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Warnings

  • WarningsIf symptoms persist more than seven days or worsen, consult a physician.If pregnant or breast-feeding, ask a healthcare professional before use.

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: 3 sprays 3 times per day.Children ages 6-12: 2 sprays 3 times per day.Use addittionlly as needed, up to 6 times per day.

Other Safety Information

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredient

Inactive Ingredients:Bio-Energetically Enhanced™ pure water, Carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

Otc - Purpose

Drug Facts____________________________________________________________________________________________________________HPUS* active ingredients                                      PurposeEqual volumes of each ingredient in 12X, 30X, and 1LM potencies.Adenosinum cyclophosphoricum.........................headache, runny noseAdrenalinum.......................hay fever, swollen sinuses, lung congestionAdrenocorticotrophin (30X).....................................congestion, coughAllium cepa..................................hay fever, sinus headache, sneezingAmbrosia artemisiaefolia................................hay fever, wheezy coughChelidonium majus.............................mucus in eyes, spasmodic coughChenopodium vulvaria....................restlessness, left-side head pressureCichorium intybus................................fatigue, headache, eye irritationCortisone aceticum......................................allergic reaction, irritabilityEuphrasia officinalis................................discharge from eyes and noseGalphimia glauca..........................................swollen eyelids, hay feverHedera helix........................catarrhal inflammation, cough with sputumHistaminum hydrochloricum........................coughing fits, itching throatJuglans cinerea..........................red, swollen eyes, sneezing, sore throatKali muriaticum...............................hoarseness, stuffy nose, nosebleedMucosa nasalis suis...........................sinus headache, nasal congestionNatrum muriaticum............................................watery eyes, sneezingPulsatilla...................................pain in head and eyes, mucus in throatRNA.......................................................................allergiec reactionsSabadilla......................................sore throat, runny nose, sneezing fitsTeucrium scorodonia....................bronchial congestion with much mucus"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopeia of the united States.

* Please review the disclaimer below.

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