Southeast Regional Allergies
FDA Label NDC 57955-8345

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Southeast Regional Allergies (NDC 57955-8345). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

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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 eyes
  • runny nose
  • sneezing
  • sore throat
  • sinus congestion
  • cough
  • stuffy nose
  • fatigue
  • itchy, irritated skin
  • hoarseness
  • headache

Warnings

Warnings

  • Stop 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

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HPUS active ingredients                                                                    Purpose

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Adenosinum cyclophosphoricum............................................headache, runny nose

Adrenalinum.......................................................................hay fever, swollen sinuses, lung congestion

Adrenocorticotrophin............................................................inflammation, congestion, cough

Allium cepa.........................................................................hay fever, sinus headache, sneezing

Alnus serrulata...................................................................hay fever

Carduus benedictus.............................................................tickling in nose

Cichorium intybus................................................................fatigue, headache

Cortisone aceticum..............................................................minor allergic reaction, irritability

Dolichos pruriens..................................................................sore throat, itchy skin

Euphrasia officinalis.............................................................discharge from eyes and nose

Galphimia glauca.................................................................swollen eyelids, hay fever

Histaminum hydrochloricum..................................................coughing, itching throat

Juglans cinerea....................................................................red swollen eyes, sneezing, sore throat

Kali muriaticum...................................................................hoarseness, stuffy nose

Mucosa nasalis suis..............................................................sinus headache, nasal congestion

Nasturtium aquaticum..........................................................urinary tract and or liver congestion

Natrum muriaticum..............................................................watery eyes, sneezing

RNA...................................................................................minor allergic reactions

Rhus toxicodendron..............................................................dry cough, sneezing, swelling of nose

Sabadilla.............................................................................sore throat, runny nose, sneezing

Sassafras officinale...............................................................swollen eyes

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