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

Coldcalm by

Drug Labeling and Warnings

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 Ingredients

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*

Warnings

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.
Do not reuse.

Uses

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

Keep out of reach of children.

Directions

Children 6 months of age and older:

Snap off single-unit dose.

Twist to open.

Squeeze entire contents into mouth.

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.

Other information

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.

*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.

Before their first birthday, most babies will catch seven colds - or more if they attend a child care center.1 . Now, at the first sign of congestion or nasal discharge in babies 6 months or older, parents can help their little one with ColdCalm®. The sterile, single-use doses prevent contamination and eliminate the need for a preservative. The clear and tasteless liquid does not contain flavors, dyes, lactose, sugar or artificial sweeteners.

Convenient, sterile single-use liquid oral doses

Perservative free

Non-drowsy, no known drug interactions

1 Mayo Clinic. Common cold in babies. Mayo Clinic. http://www. mayoclinic.org/diseases-conditions/common-cold-in babies/ home/ovc-20204277. Published May 20, 2016. Accessed November 14, 2016.

Inactive Ingredient

purified water

Questions or comments?

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

Principle Display Panel - ColdCalm

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9057
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	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]
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
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9057-07	1 in 1 PACKAGE	05/01/2017
1		5 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0220-9057-09	1 in 1 PACKAGE	05/01/2017
2		30 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		05/01/2017

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9057)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		383674934	manufacture(0220-9057)