FDA Label for Infants Gas And Colic Relief
View Indications, Usage & Precautions
Infants Gas And Colic Relief Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
Purpose
Colocynthis (Bitter apple) 6X.......................................................................upset stomach, abdominal bloating, colic and nausea
Magnesia phosphorica (Magnesium hydrogen phosphate) 6X...........................abdominal cramps
Chamomilla (German chamomile) 6X............................................................hiccups, nausea, agitation and irritability
Dioscorea villosa (Wild yam) 6X...................................................................intestinal gas, burping and colic-like pain
Uses
This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic:
• intestinal gas
• abdominal pain
• bloating & hiccups
• nausea
• burping
• upset stomach
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
Warnings
Otc - Do Not Use
Do not use if inner foil seal 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
• Do not use more than directed.
• Take 0.75 mL orally at the onset of symptoms.
• Repeat every 15 minutes up to 4 times daily, then reduce with improvement or as directed by a healthcare professional.
Age Dose
Infants and children 0 to 9 years of age 0.75 mL
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.