ColdCalm Kids
- Manufacturer
- Boiron | Boiron Inc.
- Effective date
- 2025-09-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 02:34:56
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients** (in each 1 mL vial)
Allium cepa 3C HPUS (0.125 mL)
Apis mellifica 15C HPUS (0.125 mL)
Eupatorium perfoliatum 3C HPUS (0.125 mL)
Gelsemium sempervirens 6C HPUS (0.125 mL) (contains less than 10 -11 mg gelsemine alkaloids)
Kali bichromicum 6C HPUS (0.125 mL) (contains less than 10 -10 mg chromium)
Nux vomica 3C HPUS (0.125 mL) (contains less than 10 -5 strychnine alkaloids)
Phytolacca decandra 6C HPUS (0.125 mL)
Pulsatilla 6C HPUS (0.125 mL)
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 (0.125 mL) ... Relieves sneezing and runny nose
Apis mellifica 15C HPUS (0.125 mL) ... Relieves nasal congestion
Eupatorium perfoliatum 3C HPUS (0.125 mL) ... Relieves body aches associated with colds
Gelsemium sempervirens 6C HPUS (0.125 mL) ...Relieves headaches associated with colds
Kali bichromicum 6C HPUS (0.125 mL) ... Relieves nasal discharge
Nux vomica 3C HPUS (0.125 mL) ... Relieves sneezing attacks
Phytolacca decandra 6C HPUS (0.125 mL) ... Relieves occasional minor sore throat associated with colds
Pulsatilla 6C HPUS (0.125 mL) ... 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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if sore throat is severe, accompanied or follow by fever, headache, rash, nausea, or vomiting.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- sore throat worsens or persists for more than 2 days
- nasal congestion worsens or lasts more than 5 days in children under 12 years of age
- new symptoms occur
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
Children 4 years of age and older: Give 1 dose at the onset of symptoms. Repeat up to 6 times a day. Decrease frequency with improvement.
Children under 4 years of age: Ask a doctor.
- Tear open the foil pouch at the notched edge.
- Snap off pre-measured dose.
- Twist to open.
- Holding the child upright, squeeze entire contents into mouth.
SPL UNCLASSIFIED SECTION
- do not use if glued carton end flaps are open or if inner foil pouch and vials are not intact
- do not refrigerate or freeze
- after opening foil pouch: store unused vials in the foil pouch and in the box for no longer than 3 months
- after opening the vial: use product immediately then discard
- contains 0.0015% alcohol
30 Doses
.034 fl oz (1 mL) per dose
No Known Drug Interactions
Cold Relief*
Sneezy, Runny Nose, Nasal Congestion*
*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.
INACTIVE INGREDIENT SECTION
alcohol, purified water
OTC - QUESTIONS SECTION
ColdCalm.com
BoironUSA.com
info@boiron.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc. Newtown Square, PA 19073-3267
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-9060-09 | 2023-03-01 | C162847 | 48780-1 | 9d75b9d0-d5d3-f424-e053-dadaa90a57ce | ColdCalm Kids Liquid |
| 0220-9060-09 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-d5d3-f424-e053-dadaa90a57ce | ColdCalm Kids Liquid |
| 0220-9060-09 | 2020-02-25 | C162847 | 48780-1 | 9d75b9d0-d5d3-f424-e053-dadaa90a57ce | ColdCalm Kids Liquid |
| 0220-9060-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d5d3-f424-e053-dadaa90a57ce | ColdCalm Kids Liquid |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9060-09 | ColdCalm Kids | 30 in 1 PACKAGE | LIQUID | 30 | 7 | |
| 0220-9060-09 | ColdCalm Kids | 5 in 1 POUCH | LIQUID | 5 | 7 |
Products#
Every source-derived product name is available through these pages.
- ColdCalm Kids
- STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, ONION, PHYTOLACCA AMERICANA ROOT, POTASSIUM DICHROMATE, GELSEMIUM SEMPERVIRENS ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, APIS MELLIFERA,
- ALCOHOL
- STRYCHNOS NUX-VOMICA SEED
- PULSATILLA VULGARIS
- ONION
- APIS MELLIFERA
- EUPATORIUM PERFOLIATUM FLOWERING TOP
- GELSEMIUM SEMPERVIRENS ROOT
- POTASSIUM DICHROMATE
- DICHROMATE ION
- PHYTOLACCA AMERICANA ROOT
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9060 | 0220-9060-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
| PULSATILLA VULGARIS | I76KB35JEV | ACTIB |
| ONION | 492225Q21H | ACTIB |
| APIS MELLIFERA | 7S82P3R43Z | ACTIB |
| EUPATORIUM PERFOLIATUM FLOWERING TOP | 1W0775VX6E | ACTIB |
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| POTASSIUM DICHROMATE | T4423S18FM | ACTIB |
| PHYTOLACCA AMERICANA ROOT | 11E6VI8VEG | ACTIB |
| WATER | 059QF0KO0R | IACT |
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 Kids | STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, ONION, PHYTOLACCA AMERICANA ROOT, POTASSIUM DICHROMATE, GELSEMIUM SEMPERVIRENS ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, APIS MELLIFERA, | Boiron | 6b3d8ff0-065d-85c4-e053-2991aa0a1788 | 2025-09-02 | 0220-9060-09 0220-9060 00220906009 3dd60c02-803f-c33a-e063-6294a90a0956 6b3d8ff0-065d-85c4-e053-2991aa0a1788 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.




