NDC 57955-8345 Southeast Regional Allergies

NDC Product Code 57955-8345

NDC 57955-8345-1

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 29.6 mL in 1 BOTTLE, SPRAY

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Southeast Regional Allergies with NDC 57955-8345 is a product labeled by King Bio Inc.. The generic name of Southeast Regional Allergies is . The product's dosage form is and is administered via form.

Labeler Name: King Bio Inc.

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)

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
Start Marketing Date: 10-31-2013 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Southeast Regional Allergies Product Label Images

Southeast Regional Allergies 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____________________________________________________________________________________________________________Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin,  Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Nasturtium aquaticum, Natrum muriaticum, RNA, Rhus toxicodendron, Sabadilla, Sassafras officinale.

Indications & Usage

  • Uses for temporary relief of allergy symptoms commonly experienced in AL, AR, DC, DE, FL, GA, KY, LA, MD, MS, NC, SC, TN, VA, WV:itchy, watery eyesrunny nosesneezingsore throatsinus congestioncoughstuffy nosefatigueitchy, irritated skinhoarsenessheadache

Warnings

  • WarningsStop use and ask a doctor if symptoms persist or worsen.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

  • Directions:Initially, 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 additionally as needed, up to 6 times per day.

Other Safety Information

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

Inactive Ingredient

Inactive Ingredients: Citric acid, potassium sorbate, purified water.

Otc - Purpose

Drug Facts__________________________________________________________________________________________________________________HPUS active ingredients                                                                    PurposeEqual volumes of each ingredient in 10X, 30X, and LM1 potencies.Adenosinum cyclophosphoricum............................................headache, runny noseAdrenalinum.......................................................................hay fever, swollen sinuses, lung congestionAdrenocorticotrophin............................................................inflammation, congestion, coughAllium cepa.........................................................................hay fever, sinus headache, sneezingAlnus serrulata...................................................................hay feverCarduus benedictus.............................................................tickling in noseCichorium intybus................................................................fatigue, headacheCortisone aceticum..............................................................minor allergic reaction, irritabilityDolichos pruriens..................................................................sore throat, itchy skinEuphrasia officinalis.............................................................discharge from eyes and noseGalphimia glauca.................................................................swollen eyelids, hay feverHistaminum hydrochloricum..................................................coughing, itching throatJuglans cinerea....................................................................red swollen eyes, sneezing, sore throatKali muriaticum...................................................................hoarseness, stuffy noseMucosa nasalis suis..............................................................sinus headache, nasal congestionNasturtium aquaticum..........................................................urinary tract and or liver congestionNatrum muriaticum..............................................................watery eyes, sneezingRNA...................................................................................minor allergic reactionsRhus toxicodendron..............................................................dry cough, sneezing, swelling of noseSabadilla.............................................................................sore throat, runny nose, sneezingSassafras officinale...............................................................swollen eyes

* Please review the disclaimer below.