The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Chestal Childrens Cough And Cold (NDC 0220-9068). 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 other, otc - purpose, indications & usage, otc - ask doctor, 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.
Drug Facts
Other information
• do not use if glued carton end flaps are open or if the seal at base of cap is broken or missing
• contains 4.3 g of sugar per 5 ml
• contains 0.001% alcohol
• store at 68-77°F (20-25°C)
| Active Ingredients** | Purpose* |
|---|---|
| Dulcamara 5C HPUS | Relieves colds and cough worsened by exposure to damp cold |
| Ferrum phosphoricum 9C HPUS | Relieves colds with gradual onset, minor sore throat, and dry, fitful cough |
| Hydrastis canadensis 9C HPUS | Relieves colds and cough associated with runny nose |
| Kali bichromicum 9C HPUS | Relieves nasal discharge |
| Nux vomica 9C HPUS | Relieves sneezing attacks |
The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.
**C, K, CK, and X are homeopathic dilutions: see www.boironusa.com for details.
Uses*
• temporarily relieves symptoms of the common cold such as: • nasal and chest congestion • fitful cough • sneezing • minor sore throat • runny or stuffy nose
*These uses have not been evaluated by the Food and Drug Administration.
Warnings
Ask a doctor before use if your child has:
• cough that occurs with too much phlegm (mucus) or thick, greenish phlegm, or if he/she experiences shortness of breath
• persistent or chronic cough such as occurs with asthma.
Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash or a persistent headache, or if sore throat persists for more than 2 days or occurs with a fever, headache, rash, nausea or vomiting. These could be signs of a serious condition.
Keep out of reach of children.
Directions
| Age | Dose |
|---|---|
| Children 3 to 12 years of age | Take 5 mlǂ every 2 hours |
| Children under 3 years of age | Not recommended |
ǂDosage cup included. 5 ml = 1 tsp.
Inactive ingredients
citric acid, purified water, sodium benzoate, sucrose
Questions or comments?
www.childrenschestal.com
www.boironusa.com
[email protected]
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc
6 Campus Boulevard
Newtown Square, PA 19073-3267
* Please review the disclaimer below.
