FDA Label for Coldcalm
View Indications, Usage & Precautions
Coldcalm 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 pellet)
Allium cepa 3C HPUS (0.049 mg)
Apis mellifica 6C HPUS (0.49 mg)
Belladonna 6C HPUS (0.49 mg) (contains less than 10 -15 mg atropine alkaloids)
Eupatorium perfoliatum 3C HPUS (0.49 mg)
Gelsemium sempervirens 6C HPUS (0.49 mg)
Kali birchromicum 6C HPUS
Nux Vomica 3C HPUS (0.49 mg) (contains less than 10 -8 mg strychnine alkaloids)
Phytolacca decandra 6C HPUS (0.49 mg)
Pulsatilla 6C HPUS (0.49 mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Purpose*
Allium cepa 3C HPUS (0.049 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion
Apis mellifica 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion
Belladonna 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion
Eupatorium perfoliatum 3C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion
Gelsemium sempervirens 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion
Kali birchromicum 6C HPUS ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion
Nux Vomica 3C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion
Phytolacca decandra 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion
Pulsatilla 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion
Indications & Usage
Uses*
temporarily relieves cold symptoms such as:
- sneezing
- runny nose
- nasal congestion
- minor sore throat
Warnings
Warnings
Otc - Ask Doctor
Ask a doctor before use if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 2 days or worsen, or if new symptoms occur.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, 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
Directions
- Adults and children 3 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, take 5 pellets every 6 hours. Decrease frequency with improvement.
- Children under 3 years of age: Ask a doctor.
Other
Other information
- 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
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Multi-Symptom Cold Relief*
No Known Drug Interactions
Non-Drowsy
*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.
Inactive Ingredient
lactose, sucrose
Otc - Questions
Questions or comments?
1-800-264-7661
Made in France
Distributed by
Boiron Inc.
Newtown Square, PA
19073
Package Label.Principal Display Panel
* Please review the disclaimer below.