FDA.reportPublic FDA data

SleepCalm

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-04-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:48

Label at a glance#

ProductSleepCalm
Active ingredientHYOSCYAMUS NIGER, DATURA STRAMONIUM, PASSIFLORA INCARNATA TOP, NUTMEG
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (in each pellet)

Hyoscyamus niger 3C HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids)

Nux moschata 4C HPUS (0.11 mg)

Passiflora incarnata 3X HPUS (0.11 mg)

Stramonium 6X HPUS (0.11 mg) (contains less than 10 -9 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

Hyoscyamus niger 3C HPUS (0.11 mg) ... Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.11 mg) ... Relieves restless sleep

Passiflora incarnata 3X HPUS (0.11 mg) ... Relieves sleeplessness associated with worries and exhaustion

Stramonium 6X HPUS (0.11 mg) ... Relieves sleeplessness with intermittent awakening

INDICATIONS & USAGE SECTION

Uses*

  • temporarily relieves:
  • occasional sleeplessness
  • restless sleep
  • intermittent awakening
  • helps reduce difficulty falling asleep due to:
  • nervousness
  • worries

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks or worsens. Insomnia may be a symptom of a serious underlying illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

  • Adults and children 12 years of age and older: Dissolve 5 pellets under the tongue at bedtime.
  • Children under 12 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

Melatonin-Free

Sleep Relief*

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

Calms Restless Mind*

No Known Drug Interactions

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Tube - Contains approx. 80 pellets, 3.8g, (0.13 oz)

Tube - Do not use if pellet dispenser seal is broken.

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

labellabelLabelLabellabellabellabellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9311-41SleepCalm80 in 1 TUBEPELLET803
0220-9311-42SleepCalm2 in 1 BOXPELLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9311SLEEPCALM (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM) PELLET [BOIRON]3Current NDC, Legacy NDC, 2 package rows20240430_dda7a51d-7c2c-67f4-e053-2a95a90a8e72.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-93110220-9311-41, 0220-9311-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
HYOSCYAMUS NIGER4WRK2153H3ACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
PASSIFLORA INCARNATA TOPCLF5YFS11OACTIB
SUCROSEC151H8M554IACT
NUTMEGAEE24M3MQ9ACTIB

Source Document#

Source XML

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
SleepCalmHYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUMBoirondda7a51d-7c2c-67f4-e053-2a95a90a8e722024-04-23Exact identifier
ndc (package): 0220-9311-41
ndc (package): 0220-9311-42
ndc (product): 0220-9311
ndc11 (package): 00220931142
ndc11 (package): 00220931141
spl id: 16c77587-39d7-31cf-e063-6294a90a7f22
spl set id: dda7a51d-7c2c-67f4-e053-2a95a90a8e72

Reported adverse events (FAERS/openFDA)#

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