Regional Allergies Rocky Mtns. U.s.
FDA Label NDC 57955-8200

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 Rocky Mtns. U.s. (NDC 57955-8200). 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.

Otc - Active Ingredient

Drug Facts

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HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, Agrostemma githago, Ailanthus glandulosus, Allium cepa, Cortisone aceticum, Cynodon dactylon, Equisetum hyemale, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Platanus, Populus candicans, RNA, Sabadilla, Solidago virgaurea.

Indications & Usage

Uses for temporary relief of allergy symptoms commonly experienced in AZ, CO, ID, MT, NM, NV, OR, UT, WA, WY:

  • 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 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: 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.

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

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

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

Agrimonia eupatoria.........................................................................anxiety, restlessness

Agrostemma githago........................................................................headache, vertigo, dry mouth

Ailanthus glandulosus.......................................................................hoarseness, drowsiness, dry cough

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

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

Cynodon dactylon.............................................................................swollen eyelids, loss of sense of taste

Equisetum hyemale..........................................................................heavy eyelids, sticking pain in throat

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

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

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

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

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

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

Platanus...........................................................................................weakness in eyes

Populus candicans..............................................................................sore chest and throat, hoarseness

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

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

Solidago virgaurea..............................................................................bronchitis, heavy expectoration

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