FDA Label for Pain And Fever Kids Relief
View Indications, Usage & Precautions
Pain And Fever Kids 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:
Arnica montana (Leopard's bane) 8X
Ferrum phosphoricum (Ferrosoferric phosphate) 8X
Hypericum perforatum (St John's wort) 8X
Belladonna (Deadly nightshade) 8X
Calculated as 0.0000003% alkaloids
Thuja occidentalis (White cedar) 8X
Ledum palustre (Wild rosemary) 8X
Purpose
Fever, aches and pains, headache, sore throat
Fever, inflammation
Pain in the extremities, toothache, fever
Fever, shooting pain, headache, sore throat
Sinus congestion, headache, muscular pain
Chills and fever
References
The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
RETAIN CARTON FOR COMPLETE INSTRUCTIONS
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
Otc - Do Not Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, contact a medical profesionnal or a poison control center immediately.
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 12 years old: 0.75 ml orally every 8 hours or 3 times a day.
Other Information
Store at room temperature.
Inactive Ingredients
Purified water, sorbitol, cherry flavor, sodium benzoate, potassium sorbate, citric acid.
* Please review the disclaimer below.