Midwest Regional Allergies
FDA Label NDC 57955-8315

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 Midwest Regional Allergies (NDC 57955-8315). 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, Ambrosia artemisiaefolia, Cichorium intybus, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Secale cornutum.

Indications & Usage

Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI:

  • 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

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

Cichorium intybus................................................................fatigue, headache, eye irritation

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

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

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

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

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

Hedera helix........................................................................catarrhal inflammation, cough with sputum

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

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

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

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

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

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

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

Secale cornutum...................................................................minor difficulty breathing

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