Coldcalm Liquid

Coldcalm Liquid

Drug Labeling and Warnings

Drug Details

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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Coldcalm Liquid

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

Uses

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

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.

Keep out of reach of children.

Directions

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.

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.

Inactive Ingredient

purified water

Questions or comments?

ColdCalm.com
BoironUSA.com
[email protected]
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc.
6 Campus Boulevard
Newtown Square, PA
19073-3267

Principle Display Panel - ColdCalm

sampleimage

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 0220-9057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION3 [hp_C]
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA15 [hp_C]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP3 [hp_C]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_C]
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_C]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED3 [hp_C]
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT6 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0220-9057-071 in 1 PACKAGE05/01/2017
15 in 1 POUCH; Type 0: Not a Combination Product
2NDC: 0220-9057-091 in 1 PACKAGE05/01/2017
230 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/01/2017
Labeler - Laboratoires Boiron (282560473)
Registrant - Boiron Inc. (014892269)
Establishment
NameAddressID/FEIBusiness Operations
Boiron282560473manufacture(0220-9057)
Establishment
NameAddressID/FEIBusiness Operations
Boiron383674934manufacture(0220-9057)

Revised: 12/2017
 
Laboratoires Boiron


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