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#
Contacts and useful links#
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
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9287-04 | ColdCalm | 20 in 1 BLISTER PACK | TABLET | 20 | 1 | |
| 0220-9287-04 | ColdCalm | 3 in 1 CARTON | TABLET | 3 | 1 |
Products#
Every source-derived product name is available through these pages.
- 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
- PULSATILLA VULGARIS
- ONION
- PHYTOLACCA AMERICANA ROOT
- LACTOSE
- ANHYDROUS LACTOSE
- GELSEMIUM SEMPERVIRENS ROOT
- MAGNESIUM STEARATE
- EUPATORIUM PERFOLIATUM FLOWERING TOP
- POTASSIUM DICHROMATE
- DICHROMATE ION
- CROSCARMELLOSE SODIUM
- ATROPA BELLADONNA
- APIS MELLIFERA
- STRYCHNOS NUX-VOMICA SEED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9287 | 0220-9287-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PULSATILLA VULGARIS | I76KB35JEV | ACTIB |
| ONION | 492225Q21H | ACTIB |
| PHYTOLACCA AMERICANA ROOT | 11E6VI8VEG | ACTIB |
| LACTOSE | J2B2A4N98G | IACT |
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| EUPATORIUM PERFOLIATUM FLOWERING TOP | 1W0775VX6E | ACTIB |
| POTASSIUM DICHROMATE | T4423S18FM | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| APIS MELLIFERA | 7S82P3R43Z | ACTIB |
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Boiron | 4ae2f15e-45f3-e2e4-e063-6294a90a92bc | 2026-02-15 | Warnings | 0220-9287-04 0220-9287 00220928704 4ae2f15e-45f4-e2e4-e063-6294a90a92bc 4ae2f15e-45f3-e2e4-e063-6294a90a92bc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

