COLDCALM KIDS- strychnos nux-vomica seed, pulsatilla vulgaris, onion, phytolacca americana root, potassium dichromate, gelsemium sempervirens root, eupatorium perfoliatum flowering top, apis mellifera, liquid

ColdCalm Kids by

Drug Labeling and Warnings

ColdCalm Kids by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Allium cepa 3C, Apis mellifica 15C, Eupatorium perfoliatum 3C, Gelsemium sempervirens 6C, Kali bichromicum 6C, Nux vomica 3C, Phytolacca decandra 6C, Pulsatilla 6C

PURPOSE

Allium cepa 3C Relieves sneezing and runny nose

Apis mellifica 15C Relieves nasal congestion

Eupatorium perfoliatum 3C Relieves body aches associated with colds

Gelsemium sempervirens 6C Relieves headeaches associated with colds

Kali bichromicum 6C Relieves nasal discharge

Nux vomica 3C Relieves sneezing attacks

Phytolacca decandra 6C Relieves mild fever

Pulsatilla 6C Relieves colds with a loss of taste and smell

INDICATIONS & USAGE

Temporarily relieves cold symptoms such as sneezing, runny nose, and nasal congestion.

WARNINGS

ASK DOCTOR

Ask a doctor before use in children under 6 months of age. Stop use and ask doctor if sore throat, vomiting, skin rash, diarrhea, difficulty breathing, or fever above 100 o F (38 o C) develops, or if symptoms persist for more than 2 days or worsen. After administering, discard single use container.

STOP USE

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Children 6 months of age and older:

Administer one liquid unit-dose at the onset of symptoms, 3 to 6 times a day.

Reduce with improvement.

Keep the remaining unit-doses in the aluminum pouch.

SPL UNCLASSIFIED SECTION

Do not use if glued carton end flaps, inner foil pouch, and single-user container are not intact

Before opening the foil pack: No specific storage conditions.

After opening the foil pack: Store the unused does in the foil pack at a temperature that does not exceed 77 o F (25 o C).

After opening the unit dose: The product must be used immediately.

Do not refrigerate or freeze.

INACTIVE INGREDIENT

alcohol, purified water

QUESTIONS

ColdCalm.com

BoironUSA.com

info@boiron.com

1-800-BOIRON-1 (1-800-264-7661)

Distributed by Boiron Inc.

6 Campus Boulevard

Newtown Square, PA

19073-3267

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLDCALM KIDS 
strychnos nux-vomica seed, pulsatilla vulgaris, onion, phytolacca americana root, potassium dichromate, gelsemium sempervirens root, eupatorium perfoliatum flowering top, apis mellifera, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9060
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	3 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_C]
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	3 [hp_C]
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	15 [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]
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9060-09	30 in 1 PACKAGE	05/15/2018
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/15/2018

Labeler - Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		383674934	manufacture(0220-9060)