Childrens Cough Relief
FDA Label NDC 57955-6145

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 Childrens Cough Relief (NDC 57955-6145). 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 active ingredients, inactive ingredient, purpose, dosage and administration, 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.

Label Section Quick Index

Active Ingredients

Official HPUS: Aconitum Napellus, Bromium, Coccus Cacti, Corallium Rubrum, Cuprum Metallicum, Drosera Rotundifolia, Hepar Sulphuris Calcareum, Iodium, Mephitis Mephitica and Spongia Tosta.

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Inactive Ingredient

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

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Purpose

Uses for temporary relief of minor cough symptoms from the common cold or inhaled irritants: dry or hoarse cough, tickling cough, cough from mucus drainage or throat irritation.

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Dosage And Administration

Direction: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times per day. Use additionally as needed.Adult Dose 3 pump spraysChildren (2-12 years) 2 pump spraysReference image cough.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.

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 for temporary relief of minor cough symptoms from the common cold or inhaled irritants:

  • dry or hoarse cough
  • tickling cough
  • cough from mucus drainage or throat irritation
    • Note: A persistent cough may be a sign of a serious condition. If cough is accompanied by fever, rash, persistent headache or breathing difficulties, consult a physician.

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Package Label.Principal Display Panel

Image Of Label (Cough)

Image Of Label (Cough)

King Bio, Inc.

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

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