FDA Label for Kids Relief Teething Oral Liquid
View Indications, Usage & Precautions
Kids Relief Teething Oral Liquid 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:
Chamomilla (German chamomile) 5C
Arnica montana (Leopard's bane) 5C
Borax (Sodium borate) 5C
Hypericum perforatum ( St John's wort) 5C
Otc - Purpose
Purpose
Gum pain, restlessness, irritability and agitation
Toothache and fever
Gum inflammation and diarrhea
Dental nerve pain
The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
Indications & Usage
Uses
This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething*:
• gum inflammation
• gum pain
• fever
• diarrhea
• restlessness and irritability
Warnings
Warnings
Do not use if imprinted shrink seal neckband 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 2 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.
Storage And Handling
Other Information
Store at room temperature.
Inactive Ingredient
Inactive Ingredients
Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, orange oil.
Package Label.Principal Display Panel
LABEL
CARTON
* Please review the disclaimer below.