Indications
For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability.
Comfort For Colic Liquid
FDA Label NDC 64616-116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vitality Works, Inc. for the product Comfort For Colic (NDC 64616-116). 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 indications, otc - purpose, directions, active ingredients, inactive ingredients, warnings, otc - keep out of reach of children, comments or questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability
Directions
Do not use if printed neck seal is broken or missing, use only as directed. For infants up to 3 years of age: give 4 dropsunder the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours as needed or recommended by a doctor.
Active Ingredients
Chamomilla (Chamomile) 4X, Colocynthsis (Bitter cucumber) 4X, Pulsatilla (Wind flower) 4X, Aethusa cynapium (Fools parsley) 6x, Dioscorea villosa (wild yam) 6X, Magnesia Phosphorica (Magensium phophate) 6X
Inactive Ingredients
USP Purified water, Vegetable glycerin
Warnings
Stop use and ask a doctor if
symptoms do not improve in 7 days or if new symptoms appear
if your child experiences recurring gastrointestinal upsets, frequent headaches or persistent fatigue
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.
Comments Or Questions
Health for Kids Shelbourne Falls, MA 01370 USA
1-800-255-4463
www.herbsforkids.com
* Please review the disclaimer below.
