Otc - Active Ingredient
Carbo vegetabilis 5C HPUS
Colocynthis 9C HPUS
Cuprum metallicum 5C HPUS
Coliccomfort Liquid
FDA Label NDC 0220-9074
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Coliccomfort (NDC 0220-9074). 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 otc - active ingredient, indications & usage, otc - do not use, dosage & administration, inactive ingredient, how supplied, otc - purpose, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Temporarily relieves symptoms associated with baby colic including gas pain and irritability
Otc - Do Not Use
Do not use if glued carton end flaps, inner foil pouch and single use container are not intact.
Dosage & Administration
Tear open the foil pouch, Snap off once single unit dose, Twist to open, Squeeze entire contents into the mouth.
Repeat as needed every 15 minutes for 2 more doses. For best results, administer before meals.
Inactive Ingredient
alcohol, purified water
How Supplied
30 doses of 0.34 fl. oz. each
Otc - Purpose
Carbo vegetabilis 5C HPUS .................relieves bloating associated with colic
Colocynthis 9C HPUS .....................relieves cramping pains associated with colic
Cuprum metallicum 5C HPUS ..........relieves abdominal cramps associated with colic
Storage And Handling
After opening the foil pack: store the unused doses in the foil pack at a temperature that does noe exceed 77 F (25 C)
Otc - Questions
Questions or comments?
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc.
6 Campus Blvd
Newtown Square, PA 19073-3267
Otc - Ask Doctor
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - Pregnancy Or Breast Feeding
NA
Otc - When Using
After administering, discard single use container.
Do not reuse.
After opening the single dose, the product must be used immediately. After administering, discard single use container. Do not reuse.
Other
contains 0.312% alcohol
These "uses" have not been evaluated by the Food and Drug Administration.
C, CK, CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
* Please review the disclaimer below.
