The following Structured Product Label (SPL) was submitted to the FDA by Homeolab International (canada) Inc for the product Kids Relief (NDC 71971-9216). 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:
Arnica montana 8X
(Leopard's bane)
Ferrum phosphoricum 8X
(Ferrosoferric phosphate)
Hypericum perforatum 8X
(St. John's wort)
Thuja occidentalis 8X
(White cedar)
Ledum palustre 8X (Wild rosemary)
The letters 'HPUS' indicate that the component in this product is officially
monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose
Arnica montana 8X.............................................fever, aches & pains, headache, sore throat
(Leopard's bane)
Ferrum phosphoricum 8X.....................................fever, inflammation
(Ferrosoferric phosphate)
Hypericum perforatum 8X....................................pain in the extremeties, toothache, fever
(St. John's wort)
Thuja occidentalis 8X..........................................sinus congestion, headache, muscular pain
(White cedar)
Ledum palustre 8X (Wild rosemary).....................chills and fever
Uses
This homeopathic medicine is made from a combination of
ingredients traditionally used to help temporarily reduce
fever and relieve minor aches and pains associated with:
•common cold •headache
•sore throat •toothache
Warnings
Stop use and ask a doctor in cases of high fever or if
symptoms worsen or persist for mroe than 2 days.
Keep out of reach of children. In case of accidental overdose,
contact a medical professional or a poison control center
immediately.
Directions
Children under 6 months of age: Consult a licensed healthcare
practitioner before using this product
Children under 6 months to 2 years old: 0.5 ml orally every 8 hours
or 3 times a day
Children 2 to 12 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, cherry
flavor, sodium benzoate,
potassium sorbate, citric acid.
Image Description (Box 9216)
Image Description (Label 9216)
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