Sinus Response
FDA Label NDC 58066-7013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Beaumont Bio Med for the product Sinus Response (NDC 58066-7013). 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.

Label Section Quick Index

Otc - Active Ingredient

HPUS active ingredients: Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lac defloratum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis. Equal volumes of each ingredient in 10X, 30X, 100X potencies.

Inactive Ingredient

Inactive Ingredients: Alcohol (20% v/v), Glycerin (8% v/v), in a pure water base.

Indications & Usage

Indications:​ For temporary relief of: nasal congestion, sinus pressure, sinus headaches associated with the common cold and flu.

Dosage & Administration

Directions:

  • Hold close to mouth and spray 1 dose (3 complete pump sprays) directly in mouth 4-6 times daily until symptoms improve.
  • Before initial dose, depress pump 4-5 times or until primed.
  • Consult a physician for use in children under 12 years of age.

    • Use according to label indications and/or standard homeopathic indications

Warnings

Warnings: If symptoms persist or get worse, consult a physician. If you are pregnant or nursing seek the advice of a physician before using this product.

Otc - Keep Out Of Reach Of Children

  • Keep this and all medications out of the reach of children.

Other Safety Information

Other Information: Do not use if bottle seal is broken or tampered with.

Otc - Purpose

For temporary relief of:

  • nasal congestion
  • sinus pressure
  • sinus headaches associated with the common cold and flu

* Please review the disclaimer below.