FDA Label for Kids Relief

View Indications, Usage & Precautions

Kids Relief Product Label

The following document was submitted to the FDA by the labeler of this product Homeolab International (canada) 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.

Otc - Active Ingredient



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)


Otc - Purpose



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


Indications & Usage



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



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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Dosage & Administration



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


Storage And Handling



Other information

•Store at room temperature


Inactive Ingredient



Inactive Ingredients

Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, raspberry flavour.


Kids Relief Sinus Oral Liquid




* Please review the disclaimer below.