Regional Allergies Southwestern U.s.
FDA Label NDC 57955-0761

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 Southwestern U.s. (NDC 57955-0761). 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​__________________________________________________________________________________________________________

HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin (30X), Allium cepa, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annuus, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea. Equal volumes of each ingredient in 12X, 30X, and 1LM potencies.

Indications & Usage

Uses for temporary relief of allergy symptoms commonly experienced in OK and TX: •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

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 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 ferement), steviol glycosides (stevia).

Otc - Purpose

Drug Facts

____________________________________________________________________________________________________________

HPUS active ingredients                                      Purpose

Equal volumes of each ingredient in 10X, 30X, and 1LM potencies.

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

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

Adrenocorticotrophin(30X)......................................congestion, cough

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

Asarum canadense...................................head congestion, runny nose

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

Eupatorium aromaticum...................................headache, restlessness

Euphrasia officinalis.............................itchy skin around eyes and nose

Fraxinus americana........................................nervousness, hot flushes

Galphimia glauca.............................................puffy eyelids, hay fever

Helianthus annuus.............................mucous cough, hoarse, dry throat

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

Juniperus virginiana........................................................eye twitching

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

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

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

Plantago major........................................eye, ear and face tenderness

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

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

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

Senecio jacobaea.................................fatigue, headaches, foggy mind

* Please review the disclaimer below.