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  5. Label Information: Childrens Cough Symptom Formula

FDA Label for Childrens Cough Symptom Formula

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. INACTIVE INGREDIENT
    3. PURPOSE
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. INDICATIONS & USAGE
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Childrens Cough Symptom Formula Product Label

The following document was submitted to the FDA by the labeler of this product King Bio Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.