FDA Label for Camilia Tummy
View Indications, Usage & Precautions
Camilia Tummy 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
Active ingredients** (in each 1 mL vial)
Carbo vegetabilis 6C HPUS (0.25 mL)
Chamomilla 15C HPUS (0.25 mL)
Colocynthis 9C HPUS (0.25 mL)
Cuprum metallicum 6C HPUS (0.25 mL)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Purpose*
Carbo vegetabilis 6C HPUS (0.25 mL) ... Relieves bloating and painful gas
Chamomilla 15C HPUS (0.25 mL) ... Relieves baby colic with fussiness and restlessness
Colocynthis 9C HPUS (0.25 mL) ... Relieves abdominal pain associated with baby colic
Cuprum metallicum 6C HPUS (0.25 mL) ... Relieves abdominal pain associated with baby colic
Indications & Usage
Uses*
temporarily relieves gas and colic symptoms such as:
- tummy pain
- bloating
- fussiness and crying
- excessive or painful gas
Otc - Do Not Use
Do not use if your child has a known allergy to any ingredient in this product.
Otc - Stop Use
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Children 1 month of age and older: Give 1 does at the onset of symptoms. Wait 15 minutes, then repeat if needed for up to a total of 9 doses per day. For best results, administer before meals.
1. Tear open the foil pouch at the notched edge.
2. Snap off one pre-measured dose.
3. Twist to open.
Inactive Ingredient
alcohol, purified water
Otc - Questions
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron, Inc. Newtown Square, PA 19073
Other
do not use if glued carton end flaps are open or if inner foil pouch and vials are not intact
do not refigerate
after opening foil pouch: store unused vials in the foil pouch for no longer than 3 months
after opening the vial: the product must be used immediately
after administering discard vial
do not reuse
contains 0.00008% alcohol
GAS & COLIF RELIEF*
Fussiness Bloating Painful Gas*
30 Doses
0.034 FL OZ (1 mL) per dose
99.9999% ALCOHOL-FREE
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
* Please review the disclaimer below.
