The following Structured Product Label (SPL) was submitted to the FDA by Homeolab International (canada) Inc for the product Kids Relief (NDC 71971-9066). 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, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients HPUS:
Pulsatilla 8X
(Wind flower)
Allium cepa 6X (Onion)
Arsenicum album 8X
(Arsenous oxide)
Nux Vomica 6X
(Poison nut)
Euphrasia officinalis 6X
(Eyebright)
Sabadilla 6X (Cevadilla)
Aralia racemosa 6X (Spikenard)
Cuprum metallicum 8X
(Metallic copper)
Purpose
Sinus symptoms, sneezing, nasal congestion, runny nose, itchy eyes, nose and throat, watery eyes headache, throat 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 is made from a combination of ingredients traditionally used to help relieve indispositions caused by sinus symptoms*:
• sneezing
• nasal congestion
• runny nose
• itchy eyes, nose and throat
• watery eyes
• headache
• throat 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 9 years old: 0.5 ml orally every 8 hours or 3 times a day.
Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.
Reduce intake with improvements.
In acute phase only:
Children 2 to 9 years old; Give 1 dropper (0.75ml) at the onset of symptoms. Repeat two more times at intervals of 15 minutes.
Repeat this procedure up to 6 times per day if symptoms reoccur, or as directed by a healthcare practitioner.
Not to be taken with meals
Other information
•Store at room temperature
Inactive Ingredients
Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, raspberry flavour.
Image-1 (Label 1)
Image-2 (Label 2)
* Please review the disclaimer below.
