Childrens Earache Relief
FDA Label NDC 57955-5315

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 Earache Relief (NDC 57955-5315). 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, 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.

Label Section Quick Index

Active Ingredients

Official HPUS: Aconitum napellus, Allium capa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, and Silicea.

Reference image childrens earache.jpg

Inactive Ingredient

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

Reference image childrens earache.jpg

Dosage And Administration

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed.

Adult Dose 3 pump sprays

Children 2-12 years 2 pump sprays

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Purpose

Uses for fast relief of earache symptoms:

  • ear pain
  • inflammation
  • discharge
  • fever
  • congestion
  • sensitivity to noise
  • ringing
  • throbbing
  • buzzing
  • humming
    • Reference image childrens earache.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: 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.

Reference image childrens earache.jpg

Indications And Usage

Uses for fast relief of earache symptoms: ear pain, inflammation, discharge, fever, congestion, sensitivity to noise, ringing, throbbing, buzzing, and humming.

Reference image childrens earache.jpg

Package Label.Principal Display Panel


King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com

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