SleepCalm Kids
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2024-08-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 02:27:45
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients** (in each 1 mL vial)
Chamomilla 9C HPUS (0.17 mL)
Gelsemium sempervirens 9C HPUS (0.17 mL) (contains less than 10 -17 mg gelsemine alkaloids)
Hyoscyamus niger 9C HPUS (0.17mL) (contains less than 10 -18 mg atropine alkaloids)
Kali bromatum 9C HPUS (0.17mL) (contains less than 10 -15 mg bromide)
Passiflora incarnata 3C HPUS (0.17 mL)
Starmonium 9C HPUS (0.17 mL) (contains less than 10 -18 mg atropine alkaloids)
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*
Chamomilla 9C HPUS ... Relieves restlessness, irritability, and crying during sleep
Gelsemium sempervirens 9C HPUS ... Relieves sleeplessness due to apprehension
Hyoscyamus niger 9C HPUS ... Relieves irritability and restless sleep associated with nervousness
Kali bromatum 9C HPUS ... Relieves irritability and restless sleep with night terrors
Passiflora incarnata 3C HPUS ... Relieves occasional restless sleep
Starmonium 9C HPUS ... Relieves restless sleep with intermittent awakening, nightmares and night terrors
INDICATIONS & USAGE SECTION
Uses*
- temporarily relieves symptoms of occasional sleeplessness in children associated with upsets, excitement, and schedule changes such as:
- restless sleep
- intermittent awakening
- irritability
- nightmares
- night terrors
- reduces the time to fall asleep if your child has difficulty falling asleep
OTC - DO NOT USE SECTION
Do not use if your child has a known allergy to any ingredient in this product.
OTC - STOP USE SECTION
Stop and use and ask a doctor if symptoms persist for more than 3 days or worsen. Insomnia may be a symptom of a serious underlying medical illness.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Children 3 years of age and older: Give 1 dose at bedtime, and again during the night if needed for up to a total of 2 doses per night.
Tear open the foil pouch at the notched edge. Snap off one pre-measured dose. Twist to open. 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 the foil pouch: store unused vials in the foil pouch for no longer than 3 months
after opening the vial: the product must be used immediately
after administering: discard vial
do not reuse
contains 0.0015% alcohol
Calms Restless Sleep*
Kids Sleep Aid*
Melatonin Free
15 pre-measured liquid doses
5 pre-measured liquid doses
0.34 fl oz (1 mL) each
99.99% alcohol-free
Fall Asleep, Stay Asleep
*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
BoironUSA.com Info@boiron.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron, Inc. Newtown Square, PA 19073
Made in France
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-9309-09 | 2023-02-14 | C162847 | 48780-1 | f386c64a-2b7c-0266-e053-dadaa90a7c1a | SleepCalm Kids |
| 0220-9309-09 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2b7c-0266-e053-dadaa90a7c1a | SleepCalm Kids |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9309-07 | SleepCalm Kids | 5 in 1 POUCH | LIQUID | 5 | 6 | |
| 0220-9309-09 | SleepCalm Kids | 15 in 1 POUCH | LIQUID | 15 | 6 | |
| 0220-9309-09 | SleepCalm Kids | 1 in 1 BOX | LIQUID | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0220-9309 | SLEEPCALM KIDS (MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM) LIQUID [BOIRON] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240814_aef7b774-355a-3fb8-e053-2a95a90a268c.zip |
Products#
Every source-derived product name is available through these pages.
- SleepCalm Kids
- MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM
- DATURA STRAMONIUM
- POTASSIUM BROMIDE
- BROMIDE ION
- PASSIFLORA INCARNATA FLOWERING TOP
- WATER
- ALCOHOL
- MATRICARIA CHAMOMILLA WHOLE
- GELSEMIUM SEMPERVIRENS ROOT
- HYOSCYAMUS NIGER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9309 | 0220-9309-09, 0220-9309-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DATURA STRAMONIUM | G6W4F0V8Z3 | ACTIB |
| POTASSIUM BROMIDE | OSD78555ZM | ACTIB |
| PASSIFLORA INCARNATA FLOWERING TOP | CLF5YFS11O | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| MATRICARIA CHAMOMILLA WHOLE | G0R4UBI2ZZ | ACTIB |
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| HYOSCYAMUS NIGER | 4WRK2153H3 | 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 |
|---|---|---|---|---|---|---|
| SleepCalm Kids | MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM | Boiron | aef7b774-355a-3fb8-e053-2a95a90a268c | 2024-08-09 | 0220-9309-09 0220-9309-07 0220-9309 00220930909 00220930907 1f452ffb-58f3-8ade-e063-6394a90ad0c8 aef7b774-355a-3fb8-e053-2a95a90a268c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.




