The following Structured Product Label (SPL) was submitted to the FDA by Homeolab International (canada) Inc for the product Kids Relief (NDC 71971-9021). 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, otc - purpose, indications & usage, warnings, dosage & administration, otc - keep out of reach of children, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients HPUS:
Arsenicum Album (Arsenous Oxide) 8X
Kali Phosphoricum (Dipotassium phosphate) 8X
Mercuris Solubilis (Hahnemann’s soluble mercury) 8X
Natrum Sulphuricum (Disodium sulfate) 8X
Hepar Sulphuris Calcareum (Liver of sulfur) 8X
Arum Triphyllum (Indian turnip) 8X
Purpose :
Homeopathic remedy helps relieve symptoms of sore throat, burning pain, inflammation (mucus), difficulty to swallow, hoarseness and irritation.
The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated
Uses :
This homeopathic medicine to help relieve sore throat symptoms:
• burning pain
• inflammation
• difficulty to swallow
• hoarseness
• irritation
Warnings
Do not use if seal is broken or missing.
Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.
Keep out of reach of children.
Directions
Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.
Children 6 months to 6 years old: ½ a teaspoon (2.5 ml) orally every 8 hours or 3 times a day.
Children 7 to 12 years old: 1 teaspoon (5.0 ml) orally every 8 hours or 3 times a day.
Reduce intake with improvements.
Not to be taken with meals
Keep out of reach of children.
Other information
•Store at room temperature
Inactive ingredients
Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, caramel.
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* Please review the disclaimer below.
