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

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 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, sinus and nasal congestion, and minor sore throat.

DO NOT USE

Do not use if blister seal is broken.

DOSAGE & ADMINISTRATION

Directions (adults and children 3 year of age and older)

At the onset of symptoms, take 1 dose (2 tablets) every 15 minutes for 2 hours. Then, take 1 dose every hour until symptoms are relieved.

Allow the tablets to dissolve in the mouth.

INACTIVE INGREDIENT

Croscarmellose sodium, lactose, magnesium stearate

HOW SUPPLIED

60 tablets

PURPOSE

Allium cepa 3C HPUS   Relieves sneezing and runny nose

Apis mellifica 6C Relieves nasal congestion

Belladonna 6C HPUS* Relieves colds with sudden onset

Eupatorium perfoliatum 3C HPUS  Relieves sinus pain

Gelsemium sempervirens 6C HPUS  Relieves headeaches associated with colds

Kali bichromicum 6C HPUS  Relieves nasal discharge

Nux vomica 3C HPUS* Relieves sneezing attacks

Phytolacca decandra 6C HPUS  Relieves sore throat associated with colds

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

* contains less than 10 -6 mg alkloids

STORAGE AND HANDLING

Store at 68-77 o F

QUESTIONS

Questions, Comments
www.boironusa.com
info@boironusa.com 1-800-BOIRON-1
(1-800-264-7661)
Boiron Information Center
6 campus boulevard
Newtown Square, PA
19073-3267

ASK DOCTOR

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

STOP USE

Stop use and ask a doctor if

- Symptoms persists for more than 7 days or worsen

- sore throat 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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

WHEN USING

N/A

DRUG INTERACTIONS

non-drowsy, no drug interactions.

WARNINGS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9048
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	6 [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]
DICHROMATE ION (UNII: 9LKY4BFN2V) (DICHROMATE ION - UNII:9LKY4BFN2V)	DICHROMATE ION	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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (BOIRON)	Size	9mm
Flavor		Imprint Code	;
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9048-04	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/01/1995

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/1995

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9048)