The following Structured Product Label (SPL) was submitted to the FDA by Homeolab International (canada) Inc for the product Kids Relief (NDC 71971-9083). 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, dosage & administration, warnings, otc - keep out of reach of children, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients HPUS:
Colocynthis 6X
(Bitter apple)
Magnesia phosphorica 6X
(Magnesium hydrogen phosphate)
Chamomilla 6X
(German chamomille)
Dioscorea villosa 6X
(Wild yam)
The letters 'HPUS' indicate that the component in this product is officially
monographed in the Homeopathic Pharmacopoeia of the United States)
Purpose
Colocynthis 6X...........................................abdominal bloating, colic and nausea
(Bitter apple)
Magnesia phosphorica 6X ----------------------abdominal cramps
(Magnesium hydrogen phosphate)
Chamomilla 6X ..........................................nausea, agitation and irritability
(German chamomille)
Dioscorea villosa 6X ...................................intestinal gas, burping and colic-like pain
(Wild yam)
Uses
This homeopathic medicine is made from a combination of
ingredients traditionally used to help relieve symptoms
associated with colic* •intestinal gas •abdominal pain
•bloating •nausea •burping
Directions
Children udner 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
Warnings
Do not use if bottle 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 2 days.
Keep out of reach of children.
Other information
Store at room temperature
Inactive Ingredients
Purified water, sorbitol, raspberry
and grape flavor, sodium
benzoate, potassium sorbate,
citric acid.
Image Description (Box 9083)
Image Description (Label 9083)
* Please review the disclaimer below.
