Allergy And Hay Fever
FDA Label NDC 50441-0002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmwest Inc. for the product Allergy And Hay Fever (NDC 50441-0002). 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, inactive ingredient, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, other safety information, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients: (Official HPUS) Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Sabadilla, Wyethia helenioides. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

Inactive Ingredient

Inactive Ingredients: Citric acid, potassium sorbate, pure water base.

Indications & Usage

Uses: For the temporary relief of allergy and hay fever symptoms due to seasonal allergies, rhinitus, sinus congestion and pain, itchy, red and watery eyes, sneezing, runny nose, postnasal drip, cough and sore throat. Will not cause drowsiness.

Dosage & Administration

Directions: Spray directly into mouth. Adult dose- 3 pump sprays 3 times daily. Children's Dose, (ages 2-12) 3 pump sprays, 3 times daily. Use additionally as needed.

Warnings

Warnings: If symptoms persist or worsen, stop usage and consult a physician. If pregnant or breast-feeding, take only upon advice of a healthcare professional.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Other Safety Information

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

Otc - Purpose

Uses: For the temporary relief of allergy and hay fever symptoms due to

  • seasonal allergies
  • rhinitus
  • sinus congestion and pain
  • itchy, red and watery eyes
  • sneezing
  • runny nose
  • postnasal drip
  • cough
  • sore throat
  • Will not cause drowsiness.

Package Label.Principal Display Panel

Image Description (Allergy)

Image Description (Allergy)

* Please review the disclaimer below.