CHILDREN COLDCALM- onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris pellet

Children Coldcalm by

Drug Labeling and Warnings

Children Coldcalm by is a Homeopathic medication manufactured, distributed, or labeled by Laboratoires Boiron, Boiron Inc., Boiron. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.)

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

QUESTIONS

www.boironusa.com
1-800-BOIRON-1
Newtown Square, PA
19073-3267

ASK DOCTOR

Ask a doctor before use in children younger than 3 years of age.

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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.

PREGNANCY OR BREAST FEEDING

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDREN COLDCALM 
onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9049
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	3 [hp_C]
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	5 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_C]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	3 [hp_C]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_C]
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_C]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	3 [hp_C]
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	6 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE (UNII: J2B2A4N98G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9049-42	1 in 1 BOX	09/08/2008
1	NDC: 0220-9049-41	80 in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/08/2008

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9049)