The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Camilia Tummy (NDC 0220-9099). 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, otc - purpose, indications & usage, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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
Uses*
temporarily relieves gas and colic symptoms such as:
Do not use if your child has a known allergy to any ingredient in this product.
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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.
alcohol, purified water
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron, Inc. Newtown Square, PA 19073
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.
