Allergies Formula
FDA Label NDC 57955-1700

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 Allergies Formula (NDC 57955-1700). 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.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

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HPUS active ingredients: ​Allium cepa, Ambrosia artemisiaefolia, Dulcamara, Euphrasia officinalis, Histaminum hydrochloricum, Kali muriaticum, Naphthalinum, Natrum muriaticum. Equal volumes of each ingredient in a 10X potency.

Indications & Usage

Uses for 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: Citric acid, potassium sorbate, purified water.

Warnings

Warnings

  • Stop use and ask your 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.
  • Ages 12 and up: 3 sprays 3 times per day.
  • Ages 2-12: 2 sprays 3 times per day.

Other Safety Information

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

Otc - Purpose

Uses for 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

Package Label.Principal Display Panel

Image Description (Allergies)

Image Description (Allergies)

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