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#

ProductColdCalm Kids
Active ingredientSTRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, ONION, APIS MELLIFERA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, PHYTOLACCA AMERICANA ROOT
Label structure11 sections

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.

  1. Tear open the foil pouch at the notched edge.
  2. Snap off pre-measured dose.
  3. Twist to open.
  4. 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

KUEKUELABELLABEL

j8Qj8Q

labellabel

labellabel

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9060-09ColdCalm Kids30 in 1 PACKAGELIQUID307
0220-9060-09ColdCalm Kids5 in 1 POUCHLIQUID57

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90600220-9060-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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
ColdCalm KidsSTRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, ONION, PHYTOLACCA AMERICANA ROOT, POTASSIUM DICHROMATE, GELSEMIUM SEMPERVIRENS ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, APIS MELLIFERA,Boiron6b3d8ff0-065d-85c4-e053-2991aa0a17882025-09-02Exact identifier
ndc (package): 0220-9060-09
ndc (product): 0220-9060
ndc11 (package): 00220906009
spl id: 3dd60c02-803f-c33a-e063-6294a90a0956
spl set id: 6b3d8ff0-065d-85c4-e053-2991aa0a1788

Reported adverse events (FAERS/openFDA)#

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