Otc - Active Ingredient
Active Ingredients HPUS:
Asafoetida 8X
Ignatia amara 8X
Valeriana officinalis 8X
Avena sativa 8X
Argentum nitricum 8X
Hyoscyamus niger 8X
Paeonia officinalis 8X
Stramonium 8X
Cocculus indicus 8X
Kids Relief Liquid
FDA Label NDC 71971-9104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Homeolab International (canada) Inc for the product Kids Relief (NDC 71971-9104). 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, dosage & administration, 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.
Label Section Quick Index
Otc - Purpose
Purpose of the Drug:
Asafoetida 8X..............................restlessness and anxiety
Ignatia amara 8X.........................nervousness
Valeriana officinalis 8X..................agitation
Avena sativa 8X...........................sleeplessness
Argentum nitricum 8X...................nervousness
Hyoscyamus niger 8X...................anguish and fear
Paeonia officinalis 8X....................apprehension, anxiety and irritability
Stramonium 8X............................nightmares and nervousness
Cocculus indicus 8X......................lack of concentration
The letters 'HPUS' indicate that the components in this product are officially monographed in the
Homeopathic Pharmacopoeia of the United States.
Indications & Usage
•Uses
This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of:
•Restlessness •nervousness •irritability
•agitation •sleeplessness lessens nightmares
Warnings
Warnings
Stop use and ask a doctor if symptoms worsen.
Dosage & Administration
Directions •Children under 6 months of age: Consult a
licensed healthcare practitioner before using this product
•Children 6 months to 2 years old: 2.5 ml or 1.2 teaspoon,
every 6 hours or 4 times a day •Children 2 to 12 years old:
5ml or 1 teaspoon, every 6 hours or 4 times a day.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental
overdose, contact a medical professional or a poison
control center immediately.
Storage And Handling
Other information
•Store at room temperature
•Do not use if seal is broken or missing
Inactive Ingredient
Inactive ingredients
Purified water, sorbitol, grape and rapsberry flavor,
sodium benzoate, potassium sorbate, citric acid.
Package Label.Principal Display Panel
Image Description (Calming9104 250)
Image Description (Calming9104 30)
Image Description (Calming9104 100)
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