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

ColdCalm by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients** (in each tablet)

Allium cepa 3C HPUS (0.28 mg)..

Apis mellifica 6C HPUS (0.28 mg)

Belladonna 6C HPUS (0.28 mg)(contains less than 10 -14 mg atropine alkaloids)

Eupatorium perfoliatum 3C HPUS (0.28 mg)

Gelsemium sempervirens 6C HPUS (0.28 mg)(contains less than 10 -14 mg gelsemine alkaloids)

Kali bichromicum 6C HPUS (0.28 mg)(contains less than 10 -13 mg chromium)

Nux vomica 3C HPUS (0.28 mg)(contains less than 10 -8 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.28 mg)

Pulsatilla 6C HPUS (0.28 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

Purpose*

Allium cepa 3C HPUS (0.28 mg)...................................................Relieves sneezing and runny nose

Apis mellifica 6C HPUS (0.28 mg).............................................................Relieves nasal congestion

Belladonna 6C HPUS (0.28 mg).................................................Relieves colds with a sudden onset

Eupatorium perfoliatum 3C HPUS (0.28 mg)………Relieves aches and pain associated with colds

Gelsemium sempervirens 6C HPUS (0.28 mg)……………..Relieves headaches associated with colds

Kali bichromicum 6C HPUS (0.28 mg)……………………………………….………….Relieves nasal discharge

Nux vomica 3C HPUS (0.28 mg)………………………………………..…………………Relieves sneezing fits

Phytolacca decandra 6C HPUS (0.28 mg)…Relieves occasional minor sore throat associated with colds

Pulsatilla 6C HPUS (0.28 mg)……………………................Relieves colds with a loss of taste and smell

INDICATIONS & USAGE

Uses*

temporarily relieves cold symptoms such as:

• sneezing
• runny nose
• nasal congestion
• occasional minor sore throat

WARNINGS

Do not use if you are allergic to Apis.

ASK DOCTOR

Ask a doctor before use if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting.

STOP USE

Stop use and ask doctor if

• sore throat worsens or persists for more than 2 days
• nasal congestion worsens or lasts more than 7 days
• new symptoms occur

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults 18 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets in the mouth every 6 hours. Decrease frequency with improvement.

SPL UNCLASSIFIED SECTION

Other information

• do not use if glued carton end flaps are open or if the blister seal is broken
• store below 86°F (30°C)
• retain carton for full drug facts

INACTIVE INGREDIENT

croscarmellose sodium, lactose, magnesium stearate

QUESTIONS

ColdCalm.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

COLD RELIEF*

Sneezing Runny Nose

Minor Sore Throat*

• No Known Drug Interactions
• Phenylephrine-Free
• Non-Drowsy

60 Meltaway Tablets

*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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9287
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

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: 0220-9287-04	3 in 1 CARTON	02/15/2026
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/15/2026

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9287)