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  5. Label Information: Children Coldcalm

FDA Label for Children Coldcalm

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. INACTIVE INGREDIENT
    4. HOW SUPPLIED
    5. OTC - PURPOSE
    6. STORAGE AND HANDLING
    7. OTC - QUESTIONS
    8. OTC - ASK DOCTOR
    9. OTC - STOP USE
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. OTC - WHEN USING
    12. DRUG INTERACTIONS
    13. WARNINGS
    14. DOSAGE & ADMINISTRATION
    15. OTC - PREGNANCY OR BREAST FEEDING
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children Coldcalm Product Label

The following document was submitted to the FDA by the labeler of this product Laboratoires 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



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


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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