Childrens Cough Symptom Formula
FDA Label NDC 57955-7145

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 Symptom Formula (NDC 57955-7145). 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, warnings, otc - keep out of reach of children, directions, indications & 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

HPUS active ingredients

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

Aconitum napellus, Bromium, Coccus cacti, Corallium rubrum, Cuprum metallicum, Drosera, Hepar sulphuris calcareum, Iodium, Mephitis mephitica and Spongia tosta

Inactive Ingredient

Citric acid, potassium sorbate and purified water

Purpose

HPUS active ingredients Purpose†

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

Aconitum napellus.........................................................shortness of breath, hoarse cough

Bromium........................................................................rattling cough with mucus

Coccus cacti...................................................................tickling in the throat

Corallium rubrum...........................................................rapid cough, profuse mucus

Cuprum metallicum........................................................tight chest, gurgling cough

Drosera.........................................................................deep, hoarse cough

Hepar sulphuris calcareum..............................................wheezing, choking cough

Iodium...........................................................................dry cough

Mephitis mephitica.........................................................violent coughing

Spongia tosta................................................................difficult breathing, dry throat, chest feels weak

Warnings

  • If cough persists more than 7 days, or is accompanied by fever, rash, or persistent headache, stop use and consult physician. Note: A persistent cough may be a sign of a serious condition.
  • If pregnant or breast-feeding, ask a healthcare professional before use.
  • Keep out of reach of children.

    • Other information: Tamper resistant for your protection. Use only if safety seal is intact.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children ages 2-12: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

Indications & Usage

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

  • cough with mucus
  • dry cough
  • rapid, barking cough
  • wheezing cough

    • † as per the various homeopathic Materia Medicas.

Package Label.Principal Display Panel

King Bio Inc.

3 Westside Drive

Asheville, NC 28806

For questions or more information about homeopathy call (800) 543-3245 or safe-care.com

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