FDA Label for Chestal Kids Cold And Cough
View Indications, Usage & Precautions
Chestal Kids Cold And Cough 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**
Dulcamara 5C HPUS (0.09 mg)
Ferrum phosphoricum 9C HPUS (0.09 mg)
Hydrastis canadensis 9C HPUS (0.09 mg) (contains less than 10 -20 mg hydrastine and berberine alkaloids)
Kali bichromicum 9C HPUS (0.09 mg) (contains less than 10 -19 mg chromium)
Nux Vomica 9C HPUS (0.09 mg) (contains less than 10 -20 mg strychnine alkaloids)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Purpose*
Dulcamara 5C HPUS (0.09 mg) ... Relieves cold and coughs worsened by exposure to damp cold
Ferrum phosphoricum 9C HPUS (0.09 mg) ... Relieves colds with gradual onset, occasional minor sore throat, and dry, fitful cough
Hydrastis canadensis 9C HPUS (0.09 mg) ... Relieves colds and coughs associated with runny nose
Kali bichromicum 9C HPUS (0.09 mg) (contains less than 10-19 mg chromium) ... Relieves nasal discharge
Nux Vomica 9C HPUS (0.09 mg) (contains less than 10-20 mg strychnine alkaloids) ... Relieves sneezing fits
Indications & Usage
Uses*
temporarily relieves symptoms of the common cold such as:
- nasal and chest congestion
- fitful cough
- sneezing
- occasional minor sore throat
- runny or stuff nose
Warnings
Do not use if your child is allergic to any of this product's ingredients.
Otc - Ask Doctor
Ask a doctor before use if your child has
- severe sore throat that is accompanied or followed by fever, headache, rash, nausea, or vomiting
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Otc - Stop Use
Stop use and ask a doctor if
- sore throat worsens or persists for more than 2 days
- cough or nasal congestion worsens or lasts for more than 5 days in children under 12 years of age, comes back, or is accompanied by fever, rash, or a persistent headache
- new symptoms occur. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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
- Children 4 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, dissolve 5 pellets under the tongue every 6 hours. Decrease frequency with improvement.
- Children under 4 years of age: Ask a doctor.
Inactive Ingredient
lactose, sucrose
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 pellet dispenser seal is broken
- contains 0.25 g of sugar per dose
- retain carton for full drug facts
- On-the-Go Cold & Cough Relief*
- Melts Under the Tongue
- Non-Drowsy
Turn tube upside down
Twist until 5 pellets are dispensed
Remove cap and pour pellets under the tongue
COLD & COUGH*
Nasal & Chest Congestion Cough Runny Nose*
2 TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
*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.
