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
Kids Relief Liquid
FDA Label NDC 71971-9060
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Homeolab International (canada) Inc for the product Kids Relief (NDC 71971-9060). 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.
Label Section Quick Index
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
Image Description (Label 9060)
CARTON
Image Description (Carton 9060)
* Please review the disclaimer below.
