Regional Allergies Plains U.s.
FDA Label NDC 57955-8199

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 Regional Allergies Plains U.s. (NDC 57955-8199). 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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HPUS active ingredients: Absinthium, Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Caulophyllum thalictroides, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Melilotus officinalis, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Secale cornutum.

Indications & Usage

Uses for temporary relief of allergy symptoms commonly experienced in KS, ND, NE, SD:

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

Warnings

Warnings

  • If 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

Directions:

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children 6-12 years: 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: Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Otc - Purpose

Drug Facts

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HPUS active ingredients                                                                    Purpose

Equal volumes of each ingredient in 12X, 30X, and LM1 potencies.

Absinthium.............................................................................itchy eyes, sore throat

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

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

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

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

Ambrosia artemisiaefolia...........................................................hay fever, wheezy cough

Caulopyllum thalictroides..........................................................hoarseness, panting breath

Conium maculatum..................................................................sick headache, shortness of breath

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

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

Fagopyrum esculentum............................................................red, itching eyes, headache

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

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

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

Melilotus officinalis...................................................................congestive headache, dry cough

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

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

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

Rumex crispus.........................................................................raw throat with much mucus, dry cough

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

Secale cornutum......................................................................pain in lungs, difficult breathing

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