FDA Label for Kids Relief
View Indications, Usage & Precautions
Kids Relief Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoire Atlas 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.
Otc - Active Ingredient
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
Otc - Purpose
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
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
* Please review the disclaimer below.