SleepCalm
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2025-03-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:32:25
Label at a glance#
ProductSleepCalm
Active ingredientGELSEMIUM SEMPERVIRENS ROOT, POTASSIUM BROMIDE, HYOSCYAMUS NIGER, PASSIFLORA INCARNATA FLOWERING TOP, MATRICARIA CHAMOMILLA WHOLE, DATURA STRAMONIUM
Label structure11 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients** (in each pellet)
Chamomilla 9C HPUS (0.07 mg)
Gelsemium sempervirens 9C HPUS (0.07 mg)(contains less than 10 -21 mg gelsemine)
Hyoscyamus niger 9C HPUS (0.07 mg)(contains less than 10 -22 mg atropine alkaloids)
Kali bromatum 9C HPUS (0.07 mg)(contains less than 10 -19 mg bromide)
Passiflora incarnata 3C HPUS (0.07 mg)
Stramonium 9C HPUS (0.07 mg)(contains less than 10 -21 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*
Relieves Occasional Sleeplessness, Restless Sleep, Intermittent Awakening
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 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 ingredients in this product.
OTC - STOP USE SECTION
Stop 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 overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- Children 3 years of age or older: Dissolve 5 pellets under the tongue at bedtime, and again during the night if needed, for up to a total of 2 doses per night.
- Children under 3 years of age: Ask a doctor.
INACTIVE INGREDIENT SECTION
lactose, sucrose
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
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Melatonin-Free
Kids Sleep Aid*
Tubes - contains approx. 80 pellets, 3.8g (0.13 oz)
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.
OTC - QUESTIONS SECTION
BoironUSA.com
Info@Boiron.com
1-800-264-7661
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9308-41 | SleepCalm | 80 in 1 TUBE | PELLET | 80 | 3 | |
| 0220-9308-42 | SleepCalm | 2 in 1 BOX | PELLET | 2 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0220-9308 | SLEEPCALM (MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM) PELLET [BOIRON] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250312_de0b458d-5f0a-78f4-e053-2995a90afe4b.zip |
Products#
Every source-derived product name is available through these pages.
- SleepCalm
- MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM
- GELSEMIUM SEMPERVIRENS ROOT
- POTASSIUM BROMIDE
- BROMIDE ION
- HYOSCYAMUS NIGER
- PASSIFLORA INCARNATA FLOWERING TOP
- MATRICARIA CHAMOMILLA WHOLE
- DATURA STRAMONIUM
- LACTOSE, UNSPECIFIED FORM
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9308 | 0220-9308-41, 0220-9308-42 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| POTASSIUM BROMIDE | OSD78555ZM | ACTIB |
| HYOSCYAMUS NIGER | 4WRK2153H3 | ACTIB |
| PASSIFLORA INCARNATA FLOWERING TOP | CLF5YFS11O | ACTIB |
| MATRICARIA CHAMOMILLA WHOLE | G0R4UBI2ZZ | ACTIB |
| DATURA STRAMONIUM | G6W4F0V8Z3 | ACTIB |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| SUCROSE | C151H8M554 | 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 |
|---|---|---|---|---|---|---|
| SleepCalm | MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM | Boiron | de0b458d-5f0a-78f4-e053-2995a90afe4b | 2025-03-07 | 0220-9308-42 0220-9308-41 0220-9308 00220930841 00220930842 2fc2e0fd-e440-d3f5-e063-6394a90a8473 de0b458d-5f0a-78f4-e053-2995a90afe4b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.