Allergy Hay Fever Reliever
FDA Label NDC 57955-0335

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 Allergy Hay Fever Reliever (NDC 57955-0335). 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, inactive ingredient, warnings, otc - keep out of reach of children, dosage & administration, other safety information, 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: Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, afrum triphyllum, Arundo mauritanica, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Sabadilla, Wyethia helenioides. Equal volumes of each ingredient in 10X, 30X, 1M, LM1, LM2, LM3 potencies.

Indications & Usage

Uses temporary relief of allergy and hay fever symptoms: nasal and sinus congestion, runny nose, sneezing, cough, sore throat, red, itchy or watery eyes, bronchial irritation, postnasal drip.​

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Warnings

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before ues.

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.
  • Ages 12 and up: 3 sprays 3 times per day.
  • Children 2-12: 2 sprays 3 times per day.
  • Children 2mo-2yr: 1 spray 3 times per day.

Other Safety Information

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

Otc - Purpose

Uses temporary relief of allergy and hay fever symptoms: nasal and sinus congestion, runny nose, sneezing, cough, sore throat, red, itchy or watery eyes, bronchial irritation, postnasal drip.​

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