Sore Throat And Laryngitis
FDA Label NDC 57955-5058

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 Sore Throat And Laryngitis (NDC 57955-5058). 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, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, 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__________________________________________________________________________________________________________

HPUS active ingredients                                        Purpose

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

Aconitum napellus..................................................constricted throat

Antimonium crudum...............................................rough voice from overuse

Arum triphyllum.....................................................sore throat, hoarseness

Borax...................................................................hacking cough

Causticum............................................................congestion, voice echo in ears

Ferrum phosphoricum............................................red sore throat

Graphites.............................................................hoarseness, unsteady voice

Hepar sulphuris calcareum......................................loss of voice

Kali bichromicum...................................................mucous congestion

Phosphorus...........................................................tickling in throat

Selenium metallicum..............................................laryngitis with mucus

Spongia tosta........................................................constant clearing of throat

Indications & Usage

Uses for temporary relief of minor sore throat symptoms: •dryness •burning •tickling •hoarseness •rough voice from overuse •laryngitis (loss of voice).

Warnings

Warnings

  • Severe or persistent sore throat or sore throat followed by high fever, headache, nausea, and vomiting may be serious. Consult your doctor right away.
  • Do not use more than 2 days or give to children under 3 years of age unless directed by doctor.
    • 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
  • Adults: 3 sprays 3 times per day.
  • Children Ages 3-12: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

Other Safety Information

Other Information:

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

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Otc - Purpose

Uses for temporary relief of minor sore throat symptoms:

• dryness

• burning

• tickling

• hoarseness

• rough voice from overuse

• laryngitis (loss of voice)

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