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  5. Label Information: With Calming Effect Kids Relief

FDA Label for With Calming Effect Kids Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS HPUS:
    2. PURPOSE
    3. REFERENCES
    4. USES
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. CARTON
    11. LABEL

With Calming Effect 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:



Asafoetida (Asafetida) 8X

Ignatia amara (Ignatius bean) 8X

Valeriana officinalis (Valerian) 8X

Avena sativa (Oats) 8X

Argentum nitricum (Silver nitrate) 8X

Hyoscyamus niger (Henbane) 8X

Paeonia officinalis (Peony) 8X

Stramonium (Thorn apple) 8X

Cocculus indicus (Indian berry) 8X


Purpose



Restlessness and anxiety

Nervousness

Agitation

Sleeplessness

Nervousness

Anguish and fear

Apprehension, anxiety and irritability

Nightmares and nervousness

Lack of concentration


References



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 by the Food and Drug Administration. They are based on traditional homeopathic practice.


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


Otc - Stop Use



Stop use and ask a doctor if symptoms worsen.


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.


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: 5 ml or 1 teaspoon every 6 hours or 4 times a day.


Other Information



Store at room temperature.

Do not use if seal is broken or missing.


Inactive Ingredients



Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.


* Please review the disclaimer below.