FDA Label for Coliccomfort
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- OTC - DO NOT USE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- HOW SUPPLIED
- OTC - PURPOSE
- STORAGE AND HANDLING
- OTC - QUESTIONS
- OTC - ASK DOCTOR
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - WHEN USING
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Coliccomfort Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. 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.
Otc - Active Ingredient
Carbo vegetabilis 5C HPUS
Colocynthis 9C HPUS
Cuprum metallicum 5C HPUS
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.