Sinus Relief
FDA Label NDC 57955-5134

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 Sinus Relief (NDC 57955-5134). 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, dosage and administration, purpose, warnings, otc keep out of reach of children, indications and usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc Active Ingredient

HPUS active ingredients

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies

Apis mellifica

Baptisia tinctoria

Colocynthis

Hepar sulphuris calcareum

Histaminum hydrochloricum

Hydrastis canadensis

Ignatia amara

Kali bichromicum

Lemna minor

Mercurius vivus

Pulsatilla

Rhus toxicodendron

Sabadilla

Thuja occidentalis

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Inactive Ingredient


Bio-Energetically Enhanced, taste free, pure water base.

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Dosage And Administration

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

Adult dose: 3 pump sprays 3 times per day. Use additionally as needed.

Children 2-12 years: 2 pump sprays 3 times per day. Use additionally as needed.


Reference image sinus.jpg

Purpose

HPUS active ingredients       Purpose


Apis mellifica............................swollen, red eyelids, vertigo with sneezing

Baptisia tinctoria.......................eyelids heavy, difficult breathing

Colocynthis..............................headaches, swelling of face

Hepar sulphuris calcareum.......sore nostrils, sneezing, running nose

Histaminum hydrochloricum......dries mucus membranes, sinus headache

Hydrastis canadensis...............profuse nasal discharge

Ignatia amara...........................headaches, tonsils inflamed, and swollen, dry cough

Kali bichromicum......................headaches, violent sneezing

Lemna minor............................dry throat, post-nasal dripping

Mercurius vivus........................thick mucus, runny nose, sneezing

Pulsatilla...................................itching, burning eyes, loss of smell, congestion and pain

Rhus toxicodendron..................headaches, face and throat pains

Sabadilla...................................sneezing, runny nose, sinus inflammation

Thuja occidentalis......................fever, tinnitus, vertigo

Reference image sinus.jpg

Warnings

If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

Other Information

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


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Otc Keep Out Of Reach Of Children

Keep out of reach of children.

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Indications And Usage

Uses temporarily relieves symptoms due to sinus discomforts associated with inflamed sinuses, hay fever or upper respiratory allergies:

  • sinus pain and pressure
  • runny nose
  • sinus headaches
  • sore throat
  • nasal congestion
  • dry mucus membranes
  • sneezing
  • itchy, burning eyes
  • Reference image sinus.jpg

Package Label.Principal Display Panel


Image Of Carton Label (Sinus)

Image Of Carton Label (Sinus)



King Bio Inc.

3 Westside Drive

Asheville, NC 28806

www.kingbio.com


Reference image sinus.jpg

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