Otc - Active Ingredient
Allium cepa 3C, Apis mellifica 6C, Belladonna 6C, Eupatorium perfoliatum 3C, Gelsemium sempervirens 6C, Kali bichromicum 6C, Nux vomica 3C, Phytolacca decandra 6C, Pulsatilla 6C
Children Coldcalm Pellet
FDA Label NDC 0220-9049
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Children Coldcalm (NDC 0220-9049). 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, indications & usage, inactive ingredient, how supplied, otc - purpose, storage and handling, otc - questions, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Temporary relieves cold symptoms such as sneezing, runny nose, nasal congestion and minor sore throat.
Inactive Ingredient
Lactose, Sucrose.
How Supplied
Approx. 80 pellets each, 3.8g (0.133 oz.)
Otc - Purpose
Allium cepa 3C
Apis mellifica 6C
Belladonna 6C
Eupatorium perfoliatum 3C
Gelsemium sempervirens 6C
Kali bichromicum 6C
Nux vomica 3C
Phytolacca decandra 6C
Pulsatilla 6C
Storage And Handling
Otc - Questions
www.boironusa.com
1-800-BOIRON-1
Newtown Square, PA
19073-3267
Otc - Ask Doctor
Ask a doctor before use in children younger than 3 years of age.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, or if sore throat is severe, persists for more than 2 days, or occurs with fever, headache, rash, nausea or vomiting.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - When Using
Drug Interactions
Warnings
Do not use if label sealing clear cap is broken or for sore throat in children younger than 3 years of age.
Dosage & Administration
Children 3 years of age and older: At the onset of cold symptoms, take 5 pellets every 20 minutes
for 1 hour. Then take 5 pellets every 2 hours until symptoms are relieved.
Allow the pellets to dissolve in the mouth.
Children younger than 3 year of age: Ask a doctor.
Otc - Pregnancy Or Breast Feeding
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