The following Structured Product Label (SPL) was submitted to the FDA by Laboratoire Atlas Inc for the product Kids Relief (NDC 63388-910). 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.
Active Ingredients HPUS:
Asafo etida (Asafetida) 8 [HP_ X] in 100 mL.
Ignatia amara (Ig natius bean) 8 [ HP_X] in 100 mL.
Valeriana officinalis (Valerian) 8 [HP_ X] in a 100 mL.
Avena sativa (Oats) 8 [HP_X] in a 100 mL.
Argentum nitricum (Silver nitrate) 8 [HP_X] in a 100 mL.
Hyoscyamus niger (Henbane) 8 [HP_ X] in a 100 mL.
Paeonia officinalis (Peony) 8 [ HP_ X] in a 100 ml
Stramonium (Thorn apple) 8 [HP_ X] in a 100 mL.
Cocculus indicus (Indian berry) 8
Purpose of the Drug:
[e.g. sunscreen, analgesic, etc.] Purpose
Restlessness and anxiety
Nervousness. Agitation
Sleeplessness Anguish and fear
Apprehension, anxiety and irritability
Nightmares and nervousness
Lack of concentration
The letters 'HPUS' indicate that the components in this product are officially monographed in the
Homeopathic Pharmacopoeia of the United States.
*These claims have not been reviewed or evalauted by the Food and Drug Administration. They are based on traditional homeopathic practice not
medical evidence.
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
•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
Stop use and ask a doctor if symptoms worsen.
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.
Keep out of reach of children. In case of accidental
overdose, contact a medical professional or a poison
control center immediately.
Other information
•Store at room temperature
•Do not use if seal is broken or missing
Inactive ingredients
Purified water, sorbitol, grape and rapsberry flavor,
sodium benzoate, potassium sorbate, citric acid.
Image Description (Calming9104 250)
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* Please review the disclaimer below.
