ColdCalm Tablets

Manufacturer
Boiron | Boiron, Inc.
Effective date
2026-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:37:58

Label at a glance#

ProductColdCalm
Active ingredientPULSATILLA VULGARIS, ONION, PHYTOLACCA AMERICANA ROOT, GELSEMIUM SEMPERVIRENS ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, POTASSIUM DICHROMATE, ATROPA BELLADONNA, APIS MELLIFERA, STRYCHNOS NUX-VOMICA SEED
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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 SECTION

Uses*

temporarily relieves cold symptoms such as:

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

WARNINGS SECTION

Do not use if you are allergic to Apis.

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

croscarmellose sodium, lactose, magnesium stearate

OTC - QUESTIONS SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

LABELLABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9287-04ColdCalm20 in 1 BLISTER PACKTABLET201
0220-9287-04ColdCalm3 in 1 CARTONTABLET31

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-92870220-9287-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColdCalmONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae2f15e-45f3-e2e4-e063-6294a90a92bc2026-02-15WarningsExact identifier
ndc (package): 0220-9287-04
ndc (product): 0220-9287
ndc11 (package): 00220928704
spl id: 4ae2f15e-45f4-e2e4-e063-6294a90a92bc
spl set id: 4ae2f15e-45f3-e2e4-e063-6294a90a92bc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.