FDA Label for Gas And Colic Kids Relief Baby
View Indications, Usage & Precautions
Gas And Colic Kids Relief Baby 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:
Colocynthis (Bitter apple) 6X
Magnesia phosphorica (Magnesium hydrogen phosphate) 6X
Chamomilla (German chamomile) 6X
Dioscorea villosa (Wild yam) 6X
Purpose
Abdominal bloating, colic and nausea
Abdominal cramps
Nausea, agitation and irritability
Intestinal gas, burping and colic-like pain
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 relieve symptoms associated with colic*:
• intestinal gas
• abdominal pain
• bloating
• nausea
• burping
Otc - Do Not Use
Do not use if imprinted seal under bottle cap is broken or missing.
Otc - Stop Use
Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 9 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, raspberry and grape flavor, sodium benzoate, potassium sorbate, citric acid.
* Please review the disclaimer below.