Children Coldcalm

Manufacturer: Laboratoires Boiron | Boiron Inc. | Boiron
Effective date: 2025-03-31
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 02:33:02

Label at a glance#

ProductChildren Coldcalm

Active ingredientONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS

Label structure12 sections

Contacts and useful links#

PhoneLabel contact1-800-264-7661

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (in each pellet)

Allium cepa 3C HPUS (0.05 mg)

Apis mellifica 6C HPUS (0.05 mg)

Belladonna 6C HPUS (0.05 mg)(contains less than 10 ^-15 mg atropine alkaloids)

Eupatorium perfoliatum 3C HPUS (0.05 mg)

Gelsemium sempervirens 6C HPUS (0.05 mg)(contains less than 10 ^-15 mg gelsemine alkaloids)

Kali bichromicum 6C HPUS (0.05 mg)(contains less than 10 ^-13 mg chromium)

Nux vomica 3C HPUS (0.05 mg)(contains less than 10 ^-8mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.05 mg)

Pulsatilla 6C HPUS (0.05 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 (0.05 mg)..........................................Relieves sneezing and runny nose

Apis mellifica 6C HPUS (0.05 mg)...................................................Relieves nasal congestion

Belladonna 6C HPUS (0.05 mg).......................................Relieves colds with a sudden onset

Eupatorium perfoliatum 3C HPUS (0.05 mg)…………..…Relieves body aches associated with colds

Gelsemium sempervirens 6C HPUS (0.05 mg)…….…......Relieves headaches associated with colds

Kali bichromicum 6C HPUS (0.05 mg)……………………..………………………….Relieves nasal discharge

Nux vomica 3C HPUS (0.05 mg)…………………………………………………………..Relieves sneezing fits

Phytolacca decandra 6C HPUS (0.05 mg)….Relieves occasional minor sore throat associated with colds

Pulsatilla 6C HPUS (0.05 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 your child is 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 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: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, dissolve 5 pellets under the tongue every 6 hours. Decrease frequency with improvement.

▪ Children under 4 years of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

BoironUSA.com

Info@Boiron.com

(1-800-264-7661)

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

retain carton for full drug facts

Do not use if pellet dispenser seal is broken.

COLD RELIEF*

Sneezing · Runny Nose

Nasal Congestion*

No Known Drug Interactions

Phenylephrine-Free

Non-Drowsy

2 TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Turn tube upside down

Twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

*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

LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0220-9049-42	2023-03-28	C162847	48780-1	f386c64a-2ac0-0266-e053-dadaa90a7c1a	ColdCalm Kids
0220-9049-42	2023-01-30	C162847	48780-1	f386c64a-2ac0-0266-e053-dadaa90a7c1a	ColdCalm Kids

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0220-9049-41	Children Coldcalm	80 in 1 TUBE	PELLET	80		8
0220-9049-42	Children Coldcalm	1 in 1 BOX	PELLET	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0220-9049	CHILDREN COLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS) PELLET [LABORATOIRES BOIRON]	8	Current NDC, Legacy NDC, 2 package rows	20250403_a0c35185-8ee5-4d7f-bfba-752503259cf9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
APIS MELLIFERA	ACTIVE INGREDIENT	7S82P3R43Z	2
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	2
EUPATORIUM PERFOLIATUM FLOWERING TOP	ACTIVE INGREDIENT	1W0775VX6E	2
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE INGREDIENT	639KR60Q1Q	2
ONION	ACTIVE INGREDIENT	492225Q21H	2
PHYTOLACCA AMERICANA ROOT	ACTIVE INGREDIENT	11E6VI8VEG	2
POTASSIUM DICHROMATE	ACTIVE INGREDIENT	T4423S18FM	2
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	2
STRYCHNOS NUX-VOMICA SEED	ACTIVE INGREDIENT	269XH13919	2
APIS MELLIFERA	ACTIVE MOIETY	7S82P3R43Z	2
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	2
DICHROMATE ION	ACTIVE MOIETY	9LKY4BFN2V	2
EUPATORIUM PERFOLIATUM FLOWERING TOP	ACTIVE MOIETY	1W0775VX6E	2
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE MOIETY	639KR60Q1Q	2
ONION	ACTIVE MOIETY	492225Q21H	2
PHYTOLACCA AMERICANA ROOT	ACTIVE MOIETY	11E6VI8VEG	2
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	2
STRYCHNOS NUX-VOMICA SEED	ACTIVE MOIETY	269XH13919	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Children Coldcalm
ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS
SUCROSE
LACTOSE
ONION
APIS MELLIFERA
ATROPA BELLADONNA
EUPATORIUM PERFOLIATUM FLOWERING TOP
GELSEMIUM SEMPERVIRENS ROOT
POTASSIUM DICHROMATE
DICHROMATE ION
STRYCHNOS NUX-VOMICA SEED
PHYTOLACCA AMERICANA ROOT
PULSATILLA VULGARIS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0220-9049	0220-9049-41, 0220-9049-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SUCROSE	C151H8M554	IACT
LACTOSE	J2B2A4N98G	IACT
ONION	492225Q21H	ACTIB
APIS MELLIFERA	7S82P3R43Z	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP	1W0775VX6E	ACTIB
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB
POTASSIUM DICHROMATE	T4423S18FM	ACTIB
STRYCHNOS NUX-VOMICA SEED	269XH13919	ACTIB
PHYTOLACCA AMERICANA ROOT	11E6VI8VEG	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 147 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii+route 93 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii+route 93 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii+route 54 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii+route 93 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f7e8ed4c-29c1-b08c-e053-6394a90ac8d9			a0c35185-8ee5-4d7f-bfba-752503259cf9	2023-03-27	Warnings	Exact identifier spl set id: a0c35185-8ee5-4d7f-bfba-752503259cf9

Reported adverse events (FAERS/openFDA)#

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