The following Structured Product Label (SPL) was submitted to the FDA by Laboratoire Atlas Inc for the product Infants Gas And Colic Relief (NDC 63388-643). 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 active ingredients hpus*, purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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
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.
Do not use if inner foil seal is broken or missing.
Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.
Keep out of reach of children.
• 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
Store at room temperature.
Purified water, sorbitol, raspberry and grape flavor, sodium benzoate, potassium sorbate, citric acid.
* Please review the disclaimer below.
