FDA Label for Kids Relief Ear Relief
View Indications, Usage & Precautions
Kids Relief Ear Relief Product Label
The following document was submitted to the FDA by the labeler of this product Homeolab Usa 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.
Active Ingredients Hpus*
Ferrum phosphoricum (Ferrosoferric phosphate) 30X
Capsicum annuum (Cayenne pepper) 30X
Pyrogenium (Pyrogen) 30X
Arsenicum album (Arsenous oxide) 30X
Belladonna (Deadly nightshade) 30X
Purpose
Ferrum phosphoricum (Ferrosoferric phosphate) 30X............................................sensitivity to touch
Capsicum annuum (Cayenne pepper) 30X...........................................................sensitivity to touch
Pyrogenium (Pyrogen) 30X................................................................................coldness and chilliness
Arsenicum album (Arsenous oxide) 30X...............................................................burning sensation of the ear
Belladonna (Deadly nightshade) 30X...................................................................fullness of the ear, night time calmative
References
The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
Uses
This oral homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-logged ears by helping clear water trapped in the ear.
*These statements have not been reviewed by the Food and Drug Administration. This product is manufactured using traditional homeopathic principles of dilution.
RETAIN CARTON FOR COMPLETE INSTRUCTIONS
Warnings
Do not use if imprinted shrink seal neckband is broken or missing.
Otc - Stop Use
Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Do not use more than directed.
Do not take with food.
Take 0.75 mL orally.
Repeat every 8 hours and reduce with improvement or as directed by a healthcare professional.
Infants and children 0 to 9 years of age: 0.75 mL
Other Information
Store at room temperature.
Inactive Ingredients
Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.
Carton
* Please review the disclaimer below.