The following Structured Product Label (SPL) was submitted to the FDA by Homeolab International (canada) Inc for the product Kids Relief (NDC 71971-9214). 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:
Ferrum phosphoricum 30X
(Ferrosoferic phosphate)
Capsicum annuum 30X
(Cayenne pepper)
Pyrogenium 30X
(Pyrogen)
Arsenicum album 30X
(Arsenous oxide)
The letters 'HPUS' indicate that the component in this product is officially
monographed in the Homeopathic Pharmacopoeia of the United States)
Purpose
Ferrum phosphoricum 30X ..............sensitivity to touch
(Ferrosoferic phosphate)
Capsicum annuum 30X ...................sensitivity to touch fullness of the ear
(Cayenne pepper)
Pyrogenium 30X ............................coldness and chilliness,
(Pyrogen)
Arsenicum album 30X ....................burning sensation of the ear, night time calmative
(Arsenous oxide)
Uses
This oral homeopathic medicine is made from a combination
of ingredients traditionally used to help relieve* the sensa-
tion of fullness of the ear, sensitivity to water and drafts, and
the annoyance of water-clogged ears by helping clear water
trapped in the ear.
Warnings
Stop use and ask a doctor in cases of high fever or if
symptoms worsen or persist for more than 2 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 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
Other information
•Store at room temperature
•Do not use if bottle seal is
broken or missing.
Inactive ingredients
Purified water, sorbitol, grape
and raspberry flavor, sodium
benzoate, potassium sorbate,
citric acid.
Image Description (Box 9214)
Image Description (Label 9214)
* Please review the disclaimer below.
