Allergies Foundational Formula
FDA Label NDC 66579-0065

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New Sun Inc. for the product Allergies Foundational Formula (NDC 66579-0065). 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 dosage & administration, warnings, otc - keep out of reach of children, other safety information, otc - purpose, otc - active ingredient, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Dosage & Administration

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose (2-12): 2 Pump Sprays

Warnings

Warnings:If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

Otc - Purpose

Indications: For temporary relief of allergy symptoms: •sore throat •sneezing, cough •fatigue, congestion •watery, itchy eyes

Supports a healthy, balanced immune system.

Otc - Active Ingredient

Active Ingredients: ​Adenosinum cyclophosphoricum, Adrenocorticotrophin, Allium cepa, Arsenicum album, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla. ​Equal volumes of each ingredient in 12X, 24X, LM1 potencies.

Inactive Ingredient

Inactive Ingredient: Citric acid, potassium sorbate, purified water.

Indications & Usage

Indications: For temporary relief of allergy symptoms:

  • sore throat
  • sneezing, cough
  • fatigue, congestion
  • watery, itchy eyes

    • Supports a healthy, balanced immune system.

* Please review the disclaimer below.